Final Task Plan Chapter 1

TASK PLAN FOR SUPPORTING EU INTEGRATION PROCCESS CHAPTER 1: Free movement of goods November 2015 1Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania T +355 4 2273424/2234365

This document has been compiled by Mrs Dubravka Vlašić Pleše, international expert, with thefinancial assistance of the “Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH” .The views expressed herein are those of the consultants and therefore cannot in any way be taken toreflect the official opinion of GIZ.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 2 T +355 4 2273424/2234365

TABLE OF CONTENTS1. Introduction .......................................................................................................................... 42. Screening ............................................................................................................................... 63. Chapter 1 Free movement of goods acquis ........................................................................ 8 3.1 General principles.......................................................................................................................... 8 3.2 Horizontal measures ...................................................................................................................... 9 3.3 New approach legislation .............................................................................................................. 9 3.4 Old approach legislation.............................................................................................................. 12 3.5 Procedural measures.................................................................................................................... 134. Overview of the state of play in Albania with respect to preparation for screeningprocess in Chapter 1- Free movement o goods .................................................................... 145. Principles to be applied on establishing an institutional framework for the screeningprocess regarding Chapter 1 ................................................................................................. 166. Key factors determining the concept of the Task Plan ................................................... 197. Task Plan for the project regarding the MEDTTE ........................................................ 19 7.1. Detailed organisation of the IIWG for Chapter 1 – allocation of EU acquis to relevant institutions ......................................................................................................................................... 20 7.2. Establishment of sub-groups within the IIWG for Chapter 1..................................................... 20 7.3. Establishment of the rules of procedures for the IIWG for Chapter 1........................................ 21 7.4. Mapping of stakeholders within the sector................................................................................. 22 7.5. Further analysis of the level of legislative and institutional (administrative) compliance with the acquis in Chapter 1 (Gap analysis).................................................................................................... 23 7.6. Preparation of the concept for the Strategy on Free movement of goods .................................. 23 7.7. Start of self-screening of national technical regulations against Articles 34 – 36 of TFEU ...... 24 7.8 .Information and knowledge transfer about the acquis in Chapter 1........................................... 248. Indicators for the project................................................................................................... 26Annex I - List of proposed activities with time schedules to support screening process inChapter 1................................................................................................................................. 27Annex II EU acquis screening list for chapter 1: Free movement of goods...................... 29Annex III Rules of procedures - Inter-institutional Working Group for Chapter 1 FreeMovement of GoodsAnnex IV Training Needs Assessment for Members of the Inter-Institutional WorkingGroup for Chapter 1: Free movement of goodsAnnex V Recommendations for some improvements/clarification of the generalhorizontal legislation on EU coordination mattersRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 3 T +355 4 2273424/2234365

1. IntroductionThis document is prepared under the auspices of the GIZ Project entitled: “TechnicalCooperation with Albania - Support for the Harmonisation of Economic and TradeLegislation with EU acquis”, falling under complementary Focal Area 3:„3) Preparation of accession negotiations for EU membership. Consultation will beprovided on the process for the identification of the relevant players (including the civilsociety players), setting up the structures required for conducting the negotiations, and theprocedures for the sectors for which Ministry of Economic Development, Tourism, Trade, andEntrepreneurship (hereafter referred as „MEDTTE“) is responsible. Consultation will alsobe provided on the procedures and instruments required to do the pre-screenings for thesectors for which MEDTTE is responsible.“Having in mind that MEDTTE is responsible for the harmonisation and implementation of thelarge part of the acquis and for leading the work of seven inter-institutional working groups(IIWGs), for seven chapters of the EU acquis (1, 3, 6, 7, 20, 28 and 30), MEDTTE needs tostart preparations early in advance in order to be fully ready once a negotiating date is set bythe EU. The project will, therefore, mainly support MEDTTE in preparations required till theopening and closure of screening process. For the moment the project focuses on threeselected inter-institutional working groups (for chapters 1, 3 and 28) of which this Task Plancovers activities for IIWG for Chapter 1 Free Movement of Goods.The objective of Focal Area 3 aims at preparing MEDTTE for the pre-accession negotiationperiod, more precisely for the screening process (first and second phase) and beyond. Themain objective of this assignment was to prepare a draft proposal for a Task Plan whichwould provide MEDTTE with the insight of the acquis in Chapter 1, as well as withrecommendations on how to strengthen the inter-institutional cooperation and the role ofIIWG in order to be fully aware of and prepared for the screening process in this Chapter.IIWGs were set up in 2009 for the purpose of strengthening the inter-institutional cooperationand for the reason (among other) of providing the answers to the European Commission’squestionnaire (AVIS) timely, accurately and effectively. This example has shown the addedvalue of IIWG as a body which could coordinate bulk of the work regarding the overall euro-integration process of Albania (implementation of Stabilisation and Association Agreement(SAA), National Programme for European Integration (NPEI) and Progress Report of theEuropean Commission (hereafter referred as to: the Commission)). However, during the past5 years role of IIWGs was somewhat declined for various reasons and need was recognisedfor “revitalisation” of its work and role, especially in the light of the possible opening ofnegotiation in the near future. This Task Plan will, among other things, analyse prerequisitesof the acquis in Chapter 1 so the IIWG will be able to recognise key areas on which to focusin the framework of screening process.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 4 T +355 4 2273424/2234365

The Chapter 1 represents one of the most demanding negotiating acquis chapters, because thefree movement of goods lies in the core of EU internal market. The general principle of thefree movement of goods implies that products must be traded freely from one part of theUnion to another. The free movement of goods has been a key element in creating anddeveloping the internal market. This principle is laid down by Articles 34, 35 and 36 of theTreaty on the Functioning of the European Union (TFEU), preventing Member States fromadopting and maintaining unjustified restrictions on intra-EU trade.In a number of sectors the general principle is complemented by a harmonised regulatoryframework. Horizontal measures define the quality infrastructure which Member Statesshould put in place in areas such as standardisation, conformity assessment, accreditation,metrology and market surveillance.The harmonised European product legislation, which needs to be transposed by each MemberState, represents the largest part of the acquis under this chapter. It is based on the “oldapproach” (imposing precise product specifications) and the “new and global approach”(imposing general product requirements).A series of procedural measures also require sufficient administrative capacity in order to beproperly applied. These include a notification procedure in the field of technical standards andregulations, legislation on the trade in weapons, defence products, crystal glass, footwear,textile labelling, pricing of medicinal products and on cultural goods.In the context of accession negotiation and preparation for the overall process, Chapter 1isone of the most challenging chapters in the sense of huge volume of acquis that has to betransposed. It also requires effective inter-institutional coordination and strong leadingcoordinative role of the MEDTTE in order to ensure consistency and uniform approach intransposition and implementation in all product sectors.EU enlargement negotiation process is the very complex task for state administration. After2007 enlargement accession negotiations are now organized in a systemic way under 35chapters of the acquis with introduction of the new modalities – opening and closingbenchmarks. This methodology will be also used in Albania’s accession. All of the above willhave to be ensured through several key elements of activity, which is legal harmonisationprocess, strengthening of administrative capacities (especially in the area of marketsurveillance) and policy reform.This Report consists of five main chapters, including this Introduction. The second onedescribes key characteristics of the screening process in free movement of goods. The thirdone gives an overview of the most important aspects of the acquis in Chapter 1 on which theIIWG should focus. The fourth one presents the brief current state of play in Albania withrespect to preparation for the upcoming screening in Chapter 1Free movement of goods. Theprinciples which should be applied on the current institutional framework for the screeningprocess regarding Chapter 1 are presented in the fifth chapter. Focus is given on IIWG forRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 5 T +355 4 2273424/2234365

Chapter 1 as a key negotiating vehicle and a place where national interests of Albania arediscussed and eventually built into a negotiating platform.The last two chapters are essentially the core part of the whole Report. Firstly, key factorsdetermining the concept of the overall Task Plan are described. Finally, the very last chapterof the Report is basically a plan of activities that will be implemented by the IIWG andMEDTTE till end of 2016 and beyond.2. ScreeningScreening represents the initial step in accession negotiations and is conducted separately foreach negotiating chapter. One of the basic objectives of screening is to identify the differencesexisting between the legislation of the candidate country and the EU acquis, in each of thenegotiating chapters. After the analysis, the candidate country will be expected to demonstratewhether it will be able to fully accept the EU acquis in a specific chapter and align thedifferences identified in the legislation or whether it intended to request a certain period oftransition in order to fully align and implement the legislation. As a matter of fact, accessionnegotiations are by and large negotiations on the timescale for the implementation.The phase of analytical screening of the legislation begins with the so-called “explanatory”screening within which the Commission presents to the candidate country the acquis (themost important legislation) divided into negotiating chapters. Subsequently, an assessmentwill be made, through the so-called “bilateral” screening where the candidate country presentsits legislation and situation in the sector, of the level of alignment of the candidate country’slegal system with the EU acquis and it will be determined what still needs to be done toachieve alignment with the EU acquis pending full membership.It is important to highlight that during screening a detailed scrutiny of the EU legislation andthe legislation of the candidate country is not conducted but a general overview of mostimportant selected provisions is made. Also, the current acquis is covered during thescreening process. This principle is applied even if a reform is under way and even if it isenvisaged that in short term changes in certain area of the acquis will happen (for example on-going negotiations for the so called “Product Safety and Market Surveillance Package”).During the screening process and for the purpose of the “bilateral screening”, it is possiblethat the candidate country would be asked to prepare information according to aquestionnaire submitted by the Commission. A possible problem in the provision ofrequested information is the short deadline (typically around a month).In addition to answersto the questionnaire and according to the experience from the Croatia’s accessionnegotiations, during “bilateral” screening the candidate country submits to the EuropeanCommission a screening lists, which contain a general comparison of EU and nationallegislation in table format for each area covered by screening. Again, the screening lists doRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 6 T +355 4 2273424/2234365

not provide detailed analysis by article but indicate the existence or non-existence of certainlegal or policy mechanisms for the legislation covered by screening. Although, during thescreening the representatives of the candidate country could be asked to provide the tables ofcompliance of national law and EU legal instruments, especially in those cases where thecandidate country’ position is that the national law is fully aligned with EU acquis.After the screening meetings, that is, following the completion of “bilateral” screening, theCommission will present to the Member States a Screening report containingrecommendations on the commencement of the negotiations on a specific chapter or, if soassessed by the Commission, also the opening benchmarks for specific chapter.The objective of the benchmark is to encourage the candidate country to undertake necessaryreforms and/or fulfil contractual obligations that mirror acquis requirements. Openingbenchmarks could be related to requests for the adoption of strategies and action plans,strengthening of the administrative capacities), requests for the adoption of laws and by-lawsand meeting the contractual obligations towards the EU (primarily the implementation of theStabilization and Association Agreement) etc. Opening of the negotiations on chapters forwhich opening benchmarks have been set can begin only after the EU Council decides thatthe candidate country has fulfilled those benchmarks. If the EU Screening report containsbenchmarks for opening the negotiations, the EU Council will invite Albania, after it hasassented to them, to submit its documents for fulfilling the opening benchmarks, including aseries of actions and measures that should be taken during the process of alignment with theEU system and legislation. As soon as the benchmarks for opening the negotiations on aparticular chapter are fulfilled (and the recommendations are approved by the MemberStates), the EU Council will invite Albania to present its negotiating platform/position for aspecific chapter where reached level of alignment with the EU acquis would be presented, aswell as the programme of the remaining alignment, the review of the administrativeimplementation capacities, requests for transitional periods or derogations as permanentwaivers in the implementation of the acquis in a particular area.In the case of Croatia there were three opening benchmarks for Chapter 1set. The firstreferred to the revision of horizontal legal framework, the second required the adoption ofComprehensive Strategy with the timeframe of activities for harmonisation andimplementation of Chapter 1 acquis in every specific sector (with emphasis on pharmaceuticalsector) and the third opening benchmark required the preparation and adoption of the Actionplan for harmonisation with article 34 – 36 of the Treaty on functioning of EU. Similaropening benchmark (Strategy and Action plan) have been set in the negotiations with MonteNegro and Serbia, and based on this experience, when the negotiations on Chapter 1 withAlbania start, it could be expected that the Commission will put the emphasis on thepreparation and adoption of these kind of strategic documents as well. In this respect therecommendation would be that the IIWG for Chapter 1 starts with activities and discussion onthe methodology for the preparation of similar documents.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 7 T +355 4 2273424/2234365

The closing benchmarks typically require adoption of relevant action plans and developmentof further administrative capacities, as well as later monitoring and tangible results inimplementation (track records). It might be expected close collaboration of the candidatecountry and the Commission during the drafting of the documents for the fulfilment ofopening and closing benchmarks. For its part, the Commission will provide comments so thatthese documents, once they are adopted by the national Government, could be relativelyquickly approved also by the Commission.3. Chapter 1 Free movement of goods acquis3.1 General principlesThe general principle of the free movement of goods implies that products must be tradedfreely from one part of the Union to another. The right to free movement of goods originatingin Member States, and of goods from third countries which are in free circulation in theMember States is one of the fundamental principles of the Treaty. This principle is laid downby Articles 34, 35 and 36 of the Treaty on the Functioning of the European Union(TFEU), preventing Member States from adopting and maintaining unjustified restrictions onintra-EU trade. This principle has been further developed by the jurisprudence of the Court ofJustice. Here it is important to stress that these Treaty articles do not apply when the freemovement of a given product is fully harmonized by more specific EU legislation, i.e.especially where the technical specifications of a given product or its conditions of sale aresubject to harmonization by means of directives or regulations adopted by the EU. That iswhy we say that general principles of Articles 34 – 36 apply to the products following withinnon-harmonised area. Based on the case law of the Court of Justice the principle of mutualrecognition has been established saying that any product legally manufactured and marketedin a Member State in accordance with its fair and traditional rules, and with the manufacturingprocesses of that country, must be allowed onto the market of any other Member State. Thatmeans, even in the absence of European harmonisation measures (secondary EU legislation),Member States are obliged to allow goods that are legally produced and marketed in otherMember States to circulate and to be placed on their markets.The TFEU provisions (Article 36) do not preclude prohibitions justified on grounds of publicmorality, public policy or public security, the protection of health and life of humans, animalsor plants, or the protection of industrial and commercial property, as well as other mandatoryrequirements recognised by the Court of Justice (e.g. protection of the environment). Suchprohibitions must, however, remain proportionate and must not amount to arbitrarydiscrimination or a disguised restriction on trade between Member States.Measures having equivalent effect to a quantitative restriction are prohibited subject to alimited and restrictive set of exceptions. This notably implies the elimination of technicalbarriers to trade and the compliance with the principle of mutual recognition. Sufficientadministrative arrangements are foreseen to be put in place to apply the information exchangeRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 8 T +355 4 2273424/2234365

procedures laid down in Regulation (EC) No. 764/2008of the European Parliament and ofthe Council of 9July 2008 laying down procedures relating to the application of certainnational technical rules to products lawfully marketed in another Member State and repealingDecision No 3052/95/EC and in the “strawberry” Council Regulation (EC) No 2679/98of 7December 1998 on the functioning of the internal market in relation to the free movement ofgoods among the Member States.3.2 Horizontal measuresIn a number of sectors the general principle is complemented by a harmonised regulatoryframework. Horizontal measures define the quality infrastructure which Member Statesshould put in place in areas such as standardisation, conformity assessment, accreditation,metrology and market surveillance.The adoption of the New Legislative Framework (NLF) in2008 significantly strengthened product marketing rules, the EU’s market surveillance systemand the CE mark. The main EU legal instruments regulating the marketing of the products oninternal market are the Regulation (EC) No 765/2008 of the European Parliament and of theCouncil of 9 July 2008 setting out the requirements for accreditation and market surveillancerelating to the marketing of products and repealing Regulation (EEC) No 339/93, theRegulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October2012 on European standardization and the Decision No 768/2008/EC of the EuropeanParliament and of the Council of 9 July 2008 on a common framework for the marketing ofproducts, and repealing Council Decision 93/465/EEC.Institutionally, separation of the regulatory, standardisation, accreditation and conformityassessment functions is absolutely necessary for a proper implementation of the relevantdirectives. Ideally, public authorities should retain only the legislative and enforcement(market surveillance) functions, while at the same time ensuring that the system of third partyassessment of conformity to regulatory requirements has sufficient technical competence andindependence.3.3 New approach legislationThe European Union directives, known as the \"New Approach Directives\", define \"essentialrequirements\" related to health, safety and environmental issues. Products must meet theserequirements in order to be placed on the European market. The three European StandardsOrganizations, CEN (European Committee for Standardization), CENELEC (EuropeanCommittee for Electrotechnical Standardization) and ETSI (European TelecommunicationsStandards Institute) enable these requirements to be fulfilled through the path of harmonizedEuropean Standards. If the product is in line with harmonized standards, it benefits from apresumption of conformity to the essential requirements set in the directives. A manufacturercan only place a product on the EU market when it meets all the applicable requirements. Theconformity assessment procedure is carried out before the product can be sold. Each productlegislation describes the conformity assessment procedures for each product, andmanufacturers may choose between different conformity assessment procedures, if applicable.Thee assessment is carried out either by the manufacturer or, if the applicable legislationRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 9 T +355 4 2273424/2234365

requires it, a conformity assessment body is involved. As part of conformity assessment, themanufacturer or the authorised representative must draw up a declaration of conformity(DoC). Products regulated by New approach directives bare CE marking. The very crucialpart of proper implementation of New approach directives is market surveillance which iscomplementary to conformity assessment. Both procedures help ensure the smoothfunctioning of the internal market. The New Legislative Framework from 2008 aim toimprove market surveillance, boost the quality of conformity assessments and strengthen theconditions for placing a wide range of products on the EU Market. Following its adoption theadjustments of different vertical product legislation took place. Here is the list of NewApproach product legislation1:  Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (LVD)  Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (EMC)  Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys  Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC  Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors  Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery  Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (PPE)  Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (ATEX)  Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels1Medical devices which are also covered by New approach legislation are negotiated in Chapter 28 Consumerand Health protectionRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 10 T +355 4 2273424/2234365

 Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy- related products Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (RTTE) Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (MID) Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (NAWI) Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers Commission Directive 2008/47/EC of 8 April 2008 amending, for the purposes of adapting to technical progress, Council Directive 75/324/EEC on the approximation of the laws of the Member States relating to aerosol dispensersRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 11 T +355 4 2273424/2234365

3.4 Old approach legislationCertain product sectors are regulated and harmonised on EU level by “Old approach productlegislation”, which regulates in detail and impose technical product specification2. Some ofthe product sectors negotiated in Chapter 1 and regulated by Old approach legislation aremotor vehicles and chemicals. Here is the list of EU legal instruments:  Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units  Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles  Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles  Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (CLP)  Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances  Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)  Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers  Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents  Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors2In broader sense the foodstuffs are also regulated by old approach legislation which is negotiated in Chapter12 Food safety, veterinary and phytosanitary measures, and pharmaceuticals and cosmetics are negotiated inChapter 28 Consumer and Health protectionRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 12 T +355 4 2273424/2234365

3.5 Procedural measuresThe Chapter on free movement of goods includes a series of procedural measures whichrequire sufficient administrative capacity in order to be properly applied. These include anotification procedure in the field of technical standards and regulations laid down inDirective 2015/1535/EU of the European Parliament and of the Council of 9 September 2015laying down a procedure for the provision of information in the field of technical regulationsand of rules on Information Society services repealing the Directive 98/34/EC of theEuropean Parliament and of the Council of 22 June 1998 laying down a procedure for theprovision of information in the field of technical standards and regulations. For this purposethe establishment of a central unit is an indispensable core administrative task, in order to beable to implement this acquis from the day of accession. The role of such a central unit istwofold – to receive the notifications and information that are forwarded to it from theCommission and to distribute these to the relevant ministries and departments, and to send thenotifications and information that it receives from its ministries and departments to theCommission. The exchange of information between Member States and the Commission isdone via the TRIS database (Technical Regulations Information System).Under the procedural measure also legislation on the trade in weapons and defence products isnegotiated, regulated by Council Directive 91/477/EEC of 18 June 1991 on control of theacquisition and possession of weapons, Directive 2008/51/EC of the European Parliament andof the Council of 21 May 2008 amending Council Directive 91/477/EEC on control of theacquisition and possession of weapons and Directive 2009/43/EC of the European Parliamentand of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community.Furthermore, the legislation on crystal glass, footwear, textile labelling has to also bealigned with the requirements from the Council Directive 69/493/EEC of 15 December1969 on the approximation of the laws of the Member States relating to crystal glass,Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on theapproximation of the laws, regulations and administrative provisions of the Member Statesrelating to labelling of the materials used in the main components of footwear for sale to theconsumer, Regulation (EU) No 1007/2011 of the European Parliament and of the Councilof 27 September 2011 on textile fibre names and related labelling and marking of the fibrecomposition of textile products and Commission Delegated Regulation (EU) No 286/2012of 27 January 2012 amending, in order to include a new textile fibre name, Annex I, and, forthe purposes of their adaptation to technical progress, Annexes VIII and IX to Regulation(EU) No 1007/2011 of the European Parliament and of the Council on textile fibre namesand related labelling and marking of the fibre composition of textile products.Within the part on procedural measures it is also necessary to align national legislation withCouncil Directive 89/105/EEC of 21 December 1988 relating to the transparency ofmeasures regulating the prices of medicinal products for human use and their inclusion in theRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 13 T +355 4 2273424/2234365

scope of national health insurance systems. The Chapter 1 also covers the field on freemovement of cultural goods which is regulated with Directive 2014/60/EU of the EuropeanParliament and of the Council of 15 May 2014 on the return of cultural objects unlawfullyremoved from the territory of a Member State.In addition to the above mentioned “obligatory” acquis, substantive amount of “soft” acquis(Council conclusions, recommendations, Commission guidelines etc.) also exist in this area.Although the Commission will not insist on its direct transposition, it will neverthelessdemand from the candidate country to show that it has equivalent provisions (programs oraction plans) that covers those areas dealt by the “soft” acquis.A comprehensive list of the acquis within Chapter 1 is given in Annex II to this Task Plan,together with the indication of competent authority responsible for its transposition andimplementation.4. Overview of the state of play in Albania with respect topreparation for screening process in Chapter 1- Free movement ogoodsIn its Opinion on Albania's application for membership of the European Union from 2010 theCommission stated that Albania is facing major challenges in implementing and enforcinglegislation. It has further declared that administrative capacities remain overall limited and thecountry will need sustained efforts to strengthen them to be able to assume the obligations ofmembership in the medium-term. With this regard in the Commission’s Progress report for20143 it has been reflected that the preparations in Chapter 1 Free movement of goods aremoderately advanced. Overall, legislative approximation with the acquis requires furtheraction, as well as the administrative capacities which in most of the subsectors covered byFree movement of goods need strengtheningOn 27 June 2014 Albania received the EU candidate status. Membership in the EuropeanUnion is a strategic goal fully embraced across the Albanian political spectrum.Harmonisation of legislation with EU acquis and its correct implementation are an essentialcondition for integration of Albania in European Union. Irrespective of the positiveachievements attained in specific sectors, MEDTTE and its subordinate institutions need toimprove skills in harmonisation of legislation and its implementation, together withimproving the knowledge about negotiation process and competence in conducting accessiontalks for EU membership. The Government of Albania has established the Inter-MinisterialCommittee on European Integration (KNIE) and the Inter-institutional CoordinationCommittee on European Integration (KKNIE) to lead, monitor and coordinate theimplementation of commitments undertaken under the Stabilisation and AssociationAgreement. s regards the overall coordination of EU activities at the central level, the3 The assessment of the progress in Chapter 1 will be updated following the publication of Progress Report for2015, which is expected on 12 October 2015.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 14 T +355 4 2273424/2234365

Ministry of European Integration (MEI) has been designated as the competent authority.Further to that, the EU units within sectorial ministries are also coordinating the EU activitiesat the level of each ministry.Since 2009 35 Inter-Institutional Working Groups (IIWGs) have been created for eachindividual negotiating chapter of the EU acquis. Since the IIWGs are structures already inplace, it is assumed that they will be the negotiating groups for each chapter. As such theyshould be further strengthened and tasked with the preparations of accession negotiations, ofwhich the screening is the initial phase. MEDTTE is the ministry in charged for the largestnumber of IIWGs, which there are 7 in totals. At the head of each IIWG is the deputyminister, while all the practical work is coordinated through the person of “technicalcoordinator”, member of the IIWG and usually the person responsible for administrative unitof the Ministry (which is the Free Movement of Goods Unit of MEDTTE in case of Chapter1IIWG).As regards the administrative capacities of all the actors involved in the EU integrationprocess in terms of personnel, initial impression is that it is generally understaffed. Thisespecially relates to the MEDTTE EU unit, which needs to be strengthened further, having inmind its role in future negotiations and the fact that they are responsible for coordination of 7IIWGs.The technical coordinator of IIWG for Chapter 1 has a very good knowledge on all aspects ofacquis in Chapter, but the problems within the IIWG are twofold – members of the IIWG varyand change very often, and representatives nominated on the side of some institutions do nothave enough knowledge on EU acquis requirements and are people from EU units instead theexperts from specific sectorial departments dealing with specific product legislation. TheMEDTTE and technical coordinator will have to take further efforts in reorganisation of theIIWG and identification of right representatives from line institutions. They will need to befurther familiarised with EU acquis on free movement of goods, as well as with prerequisitesof its implementation. In this regard training workshops and seminars are advised for themembers of the IIWG and MEDTTE EU unit.There has been some progress notably on horizontal issues. Quality infrastructure institutionsare well advanced in their preparation for the implementation of EU acquis, especiallystandardisation, accreditation and metrology, but crucial open issue is the lack of marketsurveillance institution. The National strategy on consumer protection and marketsurveillance, covering also accreditation, standardisation and metrology has been adopted in2015.The MEDTTE as a main coordinator of Chapter 1 has not yet launched the activitiesregarding the self-screening of national technical regulations and their compliance withArticle 34 -36 of Treaty on general principles on Free movement of goods. The Unit on FreeMovement of Goods is responsible for overall coordination in this Chapter, on regulatory partRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 15 T +355 4 2273424/2234365

of horizontal measures, as well as for the transposition of several New and Old approachlegislation. The Unit lacks administrative capacities for all these activities and additionalemployment will be needed in order to fulfil all upcoming obligations in the negotiations onChapter 1.The Free movement of goods Unit together with EU unit in MEDTTE have to be the focalpoints for elaborating the training needs of the members of the IIWG. The trainings will haveto be structured on three levels. Firstly, basic trainings on Chapter 1 acquis for newlyappointed members of the IIWG who have not so far been involved in the transpositionprocess. Secondly, the special trainings should be developed for the core members of IIWGon general principles of EU and mutual recognition in the area of free movement of goods.This part of training should also include the part on all amendments and newly adoptedhorizontal measures and vertical product legislation. Finally, the third category of trainingsshould be focused on all implementing measures and full enforcement of harmonised nationallegislation in practice. The start of this part is mostly depended on the establishment of marketsurveillance authority and its functional operation.5. Principles to be applied on establishing an institutionalframework for the screening process regarding Chapter 1Regarding the institutional framework for screening (and EU accession negotiations as awhole) it is important to note that the screening is only a (first) part of the overall negotiationprocess and activities undertaken by a candidate country on its path to the EU. The pre-screening and pre-negotiation activities should help the candidate country to establishstructures and practices necessary in order to effectively conclude this “introductory” part ofthe accession negotiations. This will also help in preparing the candidate country fornegotiations itself and further steps which are activated progressively as the accession processadvances.Generally, a candidate country determines the pace and priorities for legal and administrativeapproximation as well as institutions in charge of implementing them, whereas theCommission monitors the progress made by the candidate country and signals by means ofannual progress reports the areas in which further efforts need to be made.In this manner the candidate country advances with its preparations for future membership inthe EU even before the start of the accession negotiations. These preparations include theestablishments of a relevant administrative structure and coordination within the line ministrybut also at the level of inter-institutional cooperation. After the actual start of accessionnegotiations a good coordination of activities becomes even more important.As beginning of negotiations will get closer candidate country will be expected tosignificantly increase the effort for approximation of its legislation. In doing this the candidatecountry will not only be better prepared for future accession, but will also ensure smoothRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 16 T +355 4 2273424/2234365

continuation of the accession negotiations. Otherwise opening or closing benchmarks in areaswith relevant discrepancies could slow down the negotiation process.Screening structure and IIWG for Chapter 1The screening process is generally a “technical” exercise which should indicate to theCommission (and Member States) the level of preparedness of the candidate country for theharmonisation and implementation of EU rules in certain time-frame. Negotiations itself (in apolitical sense) are conducted at Intergovernmental conferences between the EU memberstates and the candidate country, where the most important issues are discussed, including theopening and closing of individual negotiating chapters. The candidate country is representedat the higher level (minister of foreign affairs and/or EU affairs).More specific technical issues are negotiated between the European Commission on the onehand and by a negotiating team of the candidate country on the other hand. In the case ofCroatia, members of the negotiating team were generally high officials or experts outside theadministration in charge of one of more negotiating chapters and were assisted by a workinggroup established separately for each chapter.In the case of Croatia, Working group for Chapter 1 had the task of drafting negotiatingdocuments (answers to the questionnaire, screening documents, documents for the fulfilmentof opening and closing benchmarks and negotiating position) and preparation of otherbackground materials required for negotiation purposes. In case of Albania, MEDTTE shouldbe the leading institution for drafting negotiating documents. However, it is advised to includeinto the IIWG all other interested parties as well. With this regard it will be necessary todecide when and to what extent should the other actors be included in the screening process(as members of the IIWG or some form of “external consultancy”). This relates especially toeconomic operators, business organisations and other expert associations etc. The changesfollowing the harmonisation with principles on free movement of goods will influence thesituation on Albanian market and require the adjustments of economic operators.Furthermore, structure of IIWG membership should “reflect” the acquis under this chapter,meaning that the Chapter 1 IIWG should be composed from the members of the MEDTTEand other relevant institutions, including the quality infrastructure, directly involved indrafting and implementation of the harmonised legislation. Such members should haveadequate knowledge in the acquis which is covered by them and clear responsibilities in termsof representing the views and opinions of its institution. Screening process will be conductedwithin (relatively) short timeframe and no time should be wasted in extensive proceduralmatters in getting the right response/answer.Further efforts will also be needed regarding the practical implementation of roles and dutiesof all the institutions and bodies involved in the EU integration process, which is the MEI, EUunit within MEDTTE and IIWGs. This especially relates to the need for further strengtheningRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 17 T +355 4 2273424/2234365

of capacities in terms of personnel (sufficient number). Special attention should be paid to theconnection between the function of EU unit and IIWGs as such, where the EU unit withinMEDTTE could fulfil the role of the secretariat of the IIWGs (general idea). Again, such taskshould be followed by the increase in number of personnel of the EU unit, having in mind thatMEDTTE is in charge for seven of them.All in all, once the adequate membership of the IIWG and supporting structures will beformed, it will be necessary to maintain it, with certain measures of retention policy. This laststatement is emphasised since there has been certain lack of “continuity” in institutionalknowledge during last five years following the fulfilment of the Commission’s questionnaire,exercise which the Albanian institutions have conducted professionally and successfully.As regards the possible establishment of sub-groups within the IIWG for Chapter 1,thisshould be considered taking into account existing level of cooperation among the IIWGmembers, how the relevant information is obtained and exchanged among them (easy or withsome difficulties) and in connection with that, the general working methods of the involvedinstitutions (informal or formalised). If such method will be chosen, sub-groups shouldconsist of experts from the ministry and other stakeholders specialised in a particular issue.There should be one sub-group dealing with general principles of Chapter 1 and one sub-group dealing with horizontal issues. The members of the subgroups for different productlegislation (New approach legislation) should be not just the representatives of line ministrieswith regulatory functions, but also representatives of standardisation body, accreditationbody, those dealing with conformity assessment and market surveillance authority.After the screening and negotiating documents have been prepared by the relevant ministrystaff they should be discussed within the IIWG(or its sub-group) and all its members shouldbe invited to provide necessary information, data or comments. IIWG will also be the place toexchange the information about the status in accession negotiations and thus contribute totransparency of the overall accession process.The structure of the IIWG and scope of sub-groups should be flexible in order to adapt to thechanging conditions in the accession negotiations and in particular new issues that can ariseduring negotiations. This means that the system should be in place which will allow timelyamendment of the IIWG structure (replacing or adding the new members), preferably in theform of ministerial or governmental decision.Finally, the logistics issues linked to the organisation of screening process (and negotiationsas a whole) should not be underestimated. It is thus recommended that those logistical issuesshould be coordinated by authorised staff of the MEDTTE in charge for the general logisticalsupport. As the general idea is that the EU units should serve as the secretariats for theIIWGs, it is worthwhile to consider its role to this effect.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 18 T +355 4 2273424/2234365

Governmental body which will be responsible for overall accession negotiations (probably theMEI) could provide guidelines in terms of proposed formats for negotiating documents,coordination of activities where several institutions should work together and communicatingwith Brussels.6. Key factors determining the concept of the Task PlanIn the Task Plan we will try to elaborate the first key actions which will enable an efficientstart of screening and further steps of the negotiations in Chapter 1.The efficient accession negotiations process requires a well-organised, structured andcoordinated work of IIWG, especially on the level of MEDTTE which is the leadinginstitutions for Chapter 1 acquis. For this work adequate and trained staff and permanentleadership and governance are of outmost importance. Therefore this issue is given the centralattention when defining the activities which include the institutional support in the area of freemovement of goods.The key approach and goal (in accordance with the project) of defining the activities is toraise the screening/negotiating capacities in the field of free movement of goods. The focus ison the functioning of the IIWG for Chapter1, which indirectly means strengthening ofcapacities in the MEDTTE. Task Plan tries to define strategic priorities which will producethe greatest effect in terms of preparedness for the screening process. In agreement with thepartners from MEDTTE, the activities were defined which are complementary in nature. Withthis respect this Task Plan cannot be a substitute for the activities that have to be performedby the relevant Albanian institutions.Only the activities related to the screening exercise can be precisely defined at this point. It isexpected that the screening exercise will reveal a number of other necessary tasks, which atthis point cannot yet be explicitly foreseen.Given the open date for the beginning of negotiations and the screening process for Chapter 1,it is difficult to plan other activities in advance. The presumption is that the overall screeningprocess could start by the end of 2016. But any postponement of the screening to a laterperiod would also imply postponement of other activities. Nevertheless, the proposed set ofactivities covers the period up to the end of 2016.7. Task Plan for the project regarding the MEDTTEA number of actions will be necessary to conduct in order to be effectively prepared for thescreening process as an initial phase of negotiations. The proposal is to concentrate on thefollowing activities:Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 19 T +355 4 2273424/2234365

7.1. Detailed organisation of the IIWG for Chapter 1 – allocation of EU acquis torelevant institutionsAlthough the composition of Chapter 1 IIWG mostly reflects the acquis in the area of freemovement of goods, additional amendments and changes of its structures are needed, havingin mind specific acquis that would be presented and discussed in the framework of screeningfor Chapter 1 (see the Annex II of the Task Plan). In this sense it will be also necessary toallocate relevant Albanian ministries and other institutions in charge for the each piece of theacquis, so the structure of the IIWG could be supplemented accordingly. This should be donein accordance of the new methodology for negotiations in this Chapter which wasimplemented during negotiations with Monte Negro and Serbia.Institutions involved: MEDTTE in coordination with other line institutionsTimeframe: October – December 20157.2. Establishment of sub-groups within the IIWG for Chapter 1Taking into account that Chapter 1 is one of chapters with large number of EU legalinstruments negotiated the advice is to consider possibility of establishing the sub-groupswithin the IIWG. The IIWG with more than 20 members is very difficult to coordinate and itis challenge for it to stay operational. Taking into account existing level of cooperation amongthe IIWG members, how the relevant information is obtained and exchanged among them andthe general working methods of the involved institutions (informal or formalised) it isrecommended to establish two general sub-groups and additional sub-groups based on thesimilarity of EU product legislation (e.g. one sub-group for explosives for civil use,pyrotechnic articles and ATEX). For example in Croatia, there were 14 sub-groupsestablished within the Negotiating working group on Chapter 1, and in Serbia there are17 sub-groups.Two general sub-groups should be established based on following approach: 1. The first sub-group should be responsible for all general principles and non- harmonised area. The leading institution in this sub-group should be MEDTTE. Taking into account that Albania has made a modest progress in this area it is questionable whether in the IIWG there are representatives of all necessary institutions which will have to screen national non-harmonised technical regulations. This is why in a mid-term period the membership of this sub-group will have to be extended to representatives of other ministries and institutions that have not so far taken part in the IIWG for Chapter 1. Also, here it is necessary to consider including the representatives from line institutions responsible for harmonised area in order form them to be aware not to introduce some additional rules or requirements that could be considered as national barriers to trade. In any case all members of the IIWG will haveRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 20 T +355 4 2273424/2234365

to undergo trainings on general principles of Free movement of goods and Articles 34 - 36 of the Treaty. 2. The second sub-group should be responsible for all horizontal issues on EU harmonised legislation within free movement of goods. Besides the representatives of the Unit on Free movement of goods from MEDTTE, the members of this sub-group should be the representatives of General Directorate on standardisation, General Directorate on accreditation, General Directorate on metrology, market surveillance authority, as well as representatives of other line ministries which consider it useful to participate in this horizontal sub-group and representatives of economic operators on Albanian market. This group should start the discussion on overall Strategy on free movement of goods, identifying national priority sectors which can benefit from the free access to the EU market and those national sectors for which protection from competitive pressure from the EU market has to be ensured.Institutions involved: MEDTTE and IIWG for Chapter 1Timeframe: October – December 20157.3. Establishment of the rules of procedures for the IIWG for Chapter 1The screening process and negotiation as a whole calls for efficient organisation of theactivities necessary to smoothly conduct all tasks connected with it. That means coordinationof work on documents stemming from the screening process (i.e. screening lists, variousquestionnaires etc.) and its distribution, keeping the pace of the activities having in mind setdeadlines, setting up the traveling arrangements for the members of the IIWG, etc. For this itis important to strengthen the coordination among the members of the IIWG and to clearlydefine the role of the EU unit, technical coordinator and all appointed members of the IIWG.The role of technical coordinator is crucial in setting the pace of the work of IIWG, and themembers need to be proactive and on time respond to the requests of the Secretariat andtechnical coordinator. Also the role of the IIWG in the drafting process of legal actsharmonising with acquis in Chapter 1 has to be strengthen. The legal validity and enactmentof the decisions of the IIWG has to be defined in the framework of horizontal institutionalcoordination mechanisms (See Annex V - Recommendations for someimprovements/clarification of the general horizontal legislation on EU coordination matters).Since the general idea is that the EU unit within MEDTTE should serve as the IIWGSecretariat, number of personnel, their tasks and activities related to organisation,communication, legal issues and IT support needs to be defined. According to the Croatianexperience, this team does not need to be large, but it is important for it to be able to giveefficient support to the IIWG during screening process and furthermore, during the overallnegotiation process as well.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 21 T +355 4 2273424/2234365

The methods and procedures of communication within the IIWG (including the ones with thehead of the IIWG and EU unit/Secretariat) as well as with the Commission need to bedefined. Clear working procedures and channels of communication need to be established.It is recommended that these methods are defined within the general framework ofestablishing the overall negotiating structure and procedures, since the screening process isthe integral (initial) part of the negotiations itself. Croatian experience shows necessity todraft several Government decisions/conclusions defining the rules and procedures forconducting the negotiation process. Such documents were, for instance, Government Decisionon the rights and obligations of the members of the body conducting negotiations,Government Conclusion on the obligations of state administration bodies in the process ofnegotiations, Government Decision on the procedure for drafting and adopting negotiatingpositions (including screening documents) etc.Nevertheless, taking into account the fact that there is a large number of members in the IIWGfor Chapter 1, coming from various institutions, it is recommended to establish also specialrules of procedure for that IIWG, which would define the chain of responsibilities, timeframesfor the distribution and delivery of information and data and clear lines for communicationfrom line institutions to the IIWG technical coordinator, and from IIWG, EU unit as aSecretariat to the MEI and to the Government, as well as to the European Commission (SeeAnnex III Rules Of Procedures of Inter-Institutional Working Group on Chapter FreeMovement of Goods).Institutions involved: MEDTTE, EU unit and IIWG for Chapter 1Timeframe: November 20157.4. Mapping of stakeholders within the sectorMapping will results in full identification of all relevant stakeholders for Chapter 1,development of their roles and level of their involvement in this field in different stages ofpre-accession process. Their participation should be used wisely, from providing informationto them, asking for their inputs and contribution and consulting them in the decision-makingprocess. Based on this assessment, would be possible that recommendations are provided forimprovements of the current institutional framework.Under this activity a particular focus will be given to strengthening the role of business andeconomic related NGOs, Chamber of Commerce, associations of investors, SMEs and privatecompanies which have interest of further market development and on possible changes thatwill be introduced on Albanian market following the harmonisation in Chapter 1.Institutions involved: MEDTTE, EU unit and IIWG for Chapter 1Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 22 T +355 4 2273424/2234365

Timeframe: January – June 20167.5. Further analysis of the level of legislative and institutional (administrative)compliance with the acquis in Chapter 1 (Gap analysis)Albanian institutions are largely familiarised with the acquis in Chapter 1 and significant partof it is already transposed into Albanian legislation. However, the acquis is constantlyundergoing changes and updates in line with the markets developments. It is thereforeadvisable to analyse further level of legislative and institutional compliance of Albanianlegislation and administrative capacities in the respective areas.There has been recent development and adoption of new vertical product legislation on EUlevel, based on New horizontal legislative framework from 2008. The line institutions have toanalyse the newly adopted acquis and identify the national measures for their transpositionand implementation, based on the existing methodology on how to make update of legal gapanalysis. Also the quality infrastructure institutions and members of the IIWG will have tomake a gap analysis on their administrative capacities starting from the Commission workingdocument Guide to the main administrative structures required for the implementing theacquis (February 2013). It is recommended to start in depth legislative and administrative gapanalysis in priority sectors of Chapter 1 identified by the IIWG.Institutions involved: IIWG for Chapter 1Timeframe: January 2016 – March 20177.6. Preparation of the concept for the Strategy on Free movement of goodsThe experience of Croatia and on-going negotiations with Monte Negro and Serbia show thatin regard to the adjustments to the EU market rules and ensuring the free movement of goodsthe Commission requires strategic approach from the candidate countries. The reason for thisis that the changes in market and technical rules will require certain adjustments, investmentsand costs to the economic operators. On the other side, the efficient implementation andmarket surveillance require additional resources on the side of the government of eachcandidate country. To fully envisage these consequences the process of harmonisation has tobe gradual and the economic operators should have an insight in strategic planning documentin order to be able to accommodate their business plans and adjust to the new rules andobligations on the market.During negotiations on Chapter 1 Croatian Government was requested to present the overallstrategy for harmonisation with EU acquis on free movement of goods. Similar task is set inthe form of opening benchmark for the Montenegrin and Serbian Government.Rruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 23 T +355 4 2273424/2234365

The recommendation is that Albanian Government/IIWG for Chapter 1 launches thediscussion and starts with initial phase of preparation of the concept of this kind of strategicdocument. This concept of strategy will be built on the Consumer Protection and MarketSurveillance Strategy and represent its further elaboration. The future strategy shouldrepresent the key document of gradual approximation and on prioritisation in Chapter 1.Institutions involved: IIWG for Chapter 1 – sub-group on horizontal issuesTimeframe: January – July 20167.7. Start of self-screening of national technical regulations against Articles 34 –36 of TFEUAlbanian administration has not yet started with analysis of national technical regulationsfalling within non-harmonised area on EU level. These national regulations have to be in linewith Articles 34 – 36 of the TFEU. The experience of Croatia, as well as other countriescurrently negotiating is that the Commission requests the presentation of comprehensiveAction plan on activities concerning the self-screening of national technical regulations andon introduction of mutual recognition clause. The recommendation is that IIWG on Chapter 1starts with preparatory activities and self-screening of national technical regulations inadvance, before the screening starts. This may not in full be enough to prevent theCommission in setting the opening benchmark but could contribute to better understanding ofthe requirements of the Treaty and contribute to proper preparation for screening. In thisregard the IIWG should prepare the methodology for this self-screening exercise, defining theinstruments and steps in the process. This could be developed from the beginning of 2016 tillJune 2016. In order to be able to perform this self-screening exercise the members of theIIWG will have to undergo additional trainings on Articles 34 – 36 of the TFEU and onjurisprudence of the Court of Justice related to free movement of goods. The timescale fortrainings would be second half of 2016. Following these preparatory activities in 2017 theself—screening should be done in one or two pilot product sectors, which should serve asexamples of best practice that could be applied in all other areas.Institutions involved: IIWG for Chapter 1Timeframe: January 2016 –June 20187.8 .Information and knowledge transfer about the acquis in Chapter 1Constant improvement of knowledge about the acquis is a prerequisite for successfulconduction of negotiations, especially during the screening process as its initial phase.Candidate country must have adequate pre-knowledge about the acquis and its demands, eventhough the screening is the process where the Commission introduces relevant acquis to theRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 24 T +355 4 2273424/2234365

candidate country. If the candidate country waits to be familiarised with the acquis onlyduring the screening process, it will lose valuable time needed for successful finishing of thisinitial phase, which could furthermore delay overall negotiation process. After the screeningprocess (and depending on whether the opening benchmarks will be set) candidate countryneeds to explain its readiness to transpose and implement the acquis upon accession to theEU, which is presented in its negotiating position. All of this is possible only if the candidatecountry possesses thorough knowledge about the acquis and what is needed for its institutionsto be able to transpose it and implement it on time. Recommendation is therefore that withinthe project the IIWG gets engaged in the preparation of Training needs assessment (TNA isprovided in the Annex IV of the Task plan). Following that further trainings(seminars/workshops) for the members of the IIWG and MEDTTE EU unit about the acquisin Chapter 1 will be organised. It is recommended that it is done in four separate modules: 1. Basic trainings on Chapter 1 acquis – the beneficiaries of this module would be newly appointed members of the IIWG. Following the new allocation of Chapter 1 acquis and clear identification of civil servants responsible for one piece of EU legislation, there will be some “newcomers” who will need trainings on basic principles of EU acquis on Chapter 1. This module could be organised by MEDTTE, and the trainers would be the technical coordinator of Chapter 1 and representatives of EU unit in MEDTTE.2. Advanced trainings on amendments and newly adopted horizontal measures and vertical product legislation – this module would be comprised of several one-day workshops on specific EU acquis in Chapter 1, for specific sub-group on vertical product legislation. The module would need to be developed in close cooperation with IIWG for Chapter 1 in order to identify the areas (New and Old approach legislation) in which there is a lack of experience and knowledge and trainings are of utmost importance for successful preparation for the screening process.3. Advanced trainings on Article 34 -36 of the TFEU and non-harmonised area - this module will be developed for the core members of IIWG (sub-group on general principles of free movement of goods and non-harmonised area). The trainers would be experts from MS with the experience in this area.4. Trainings on implementing measures and enforcement of harmonised national legislation in practice – this module will need to be developed following the establishment of market surveillance authority. The workshops and seminars within this module would be designed for employees for the market surveillance authority. The trainings should combine theoretical part with practical exercise on the field, involving the peer to peer exchange of best practices.This is of course not the exhaustive list of possible modules because the further training willdepend on the finalisation of the Training need assessment. Also during the process someRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 25 T +355 4 2273424/2234365

other areas may be identified as priority areas where additional transfer of knowledge isrequired.Within activity it is important to envisage the nee of sharing information among the membersof the IIWG as well as provide the data on the state of play in Chapter 1 to other interestedparties. There are different tools and instruments that should be considered in this regards, aspreparation of different background materials, guidelines and usage of Documentmanagement system application.Institutions involved: MEDTTE, IIWG for Chapter 1, State school for public administrationTimeframe: November 2015 – December 20168. Indicators for the projectGlobal indicator 1: Definition of responsibilities for each EU acquis act under chapter 1Global indicator 2: Final structure, sub-groups and membership of the IIWG for Chapter 1 is establishedGlobal indicator 3: Rules of procedures for IIWG for Chapter 1 are developed and shared with the group including defined activities/tasks and methods of communication with EU unit within Ministry and with other line ministriesGlobal indicator 4: Mapping of stakeholders developedGlobal indicator 5: Update of legal and administrative gap analysis conducted in priority sectors identifiedGlobal indicator 6: Concept of the Strategy on free movement of goods developedGlobal indicator 7 Methodology for the self-screening of national technical regulations against Articles 34 – 36 of the TFEU prepared Trainings of the members of IIWG on Articles 34 – 36 of the TFEU delivered Pilot self-screening exercise for one or two sectors performedGlobal indicator 8 Training needs assessment developed Trainings delivered – basic and advanced seminars and workshops for the members of IIWG and MEDTTE EU unit have been conducted Instruments and tools for dissemination of knowledge definedRruga Ismail Qemali, No3, 2nd Floor, Tirana, Albania 26 T +355 4 2273424/2234365

Annex I - List of proposed activities with time sched Activity Responsibility MEDTTE, other lines institutions7.1. Detailed organisation of theIIWG for Chapter 1 – allocation of MEDTTE and IIWGEU acquis to relevant institutions7.2. Establishment of sub-groupswithin the IIWG for Chapter 17.3 Establishment of the rules of MEDTTE, EU unit and IIWGprocedures for the IIWG forChapter 1 MEDTTE, EU unit and IIWG7.4. Mapping of stakeholders IIWG for Chapter1within the sector7.5 Further analysis of the level of IIWG for Chapter 1 – sub-group onlegislative and institutional horizontal issues(administrative) compliance with IIWG for Chapter 1the acquis in Chapter 1(Gapanalysis)7.6 Preparation of the concept forthe Strategy on Free movement ofgoods7.7 Start of self-screening ofnational technical regulationsagainst Articles 34 – 36 of TFEU Rruga Ismail Qemali, No3, T +355 4 2273

dules to support screening process in Chapter 1 Timeframe Indicators of successOctober – December 2015 Definition of responsibilities for each EU acquis act under Chapter 1October – December 2015 Final structure, sub-groups andNovember 2015 membership of the IIWG for Chapter 1 is established,January – June 2016 Rules of procedures for IIWG ofJanuary 2016 – March 2017 Chapter 1 are developed and shared with the group Mapping of stakeholders developed Update of legal and administrative gap analysis conducted in priority sectors identified January – July 2016 Concept of the Strategy on free January 2016– July 2018 movement of goods developed 2nd Floor, Tirana, Albania Methodology for the self-screening3424/2234365 of national technical regulations against Articles 34 – 36 of the TFEU prepared Trainings of the members of IIWG 27

7.8.Information and knowledge MEDTTE, IIWG for Chapter 1,transfer about the acquis in Chapter State school for public1 administration Rruga Ismail Qemali, No3, T +355 4 2273

on Articles 34 – 36 of the TFEU deliveredNovember 2015 – December 2016 Pilot self-screening exercise for one or two sectors performed Training needs assessment developed Trainings delivered – basic and advanced seminars and workshops for the members of IIWG and MEDTTE EU unit have been conducted Instruments and tools for dissemination of knowledge defined 2nd Floor, Tirana, Albania 283424/2234365

Annex II EU acquis screening list for chapter 1: FreCelex Nr EuMeas TitleC2010/083/01 1.1. General principles32008R0764 Articles 34, 35 and 36 of the Treaty on the Function31998R2679 Union (TFEU);32008R0765 Regulation (EC) No. 764/2008 of the European Pa32012R1025 Council of 9July 2008 laying down procedures relating certain national technical rules to products lawfully Member State and repealing Decision No 3052/95/EC Council Regulation (EC) No 2679/98 of 7 Dece functioning of the internal market in relation to the free among the Member States. 1.2. Horizontal measures Regulation (EC) No 765/2008 of the European Pa Council of 9 July 2008 setting out the requirements market surveillance relating to the marketing of pro Regulation (EEC) No 339/93 Regulation (EU) No 1025/2012 of the European P Council of 25 October 2012 on European standardizatio Rruga Ismail Qemali, No3, T +355 4 2273

ee movement of goods Suggested RespAuth/ Level of Collaborators Harmonisation RespAuthning of the European METEarliament and of theg to the application of marketed in another METEember 1998 on thee movement of goods METEarliament and of the for accreditation andoducts and repealing METEParliament and of theon METE 2nd Floor, Tirana, Albania 293424/2234365

Celex Nr EuMeas Title32008D0768 Decision No 768/2008/EC of the European Parliament 9 July 2008 on a common framework for the marke32014L0035 repealing Council Decision32014L003032009L0048 1.3. New approach legislation32014L0033 Directive 2014/35/EU of the European Parliament and32006L0042 February 2014 on the harmonisation of the laws of32000L0014 relating to the making available on the market of designed for use within certain voltage limits (LVD) Directive 2014/30/EU of the European Parliament and February 2014 on the harmonisation of the laws of relating to electromagnetic compatibility (EMC) Directive 2009/48/EC of the European Parliament and June 2009 on the safety of toys Directive 2014/33/EU of the European Parliament and February 2014 on the harmonisation of the laws of relating to lifts and safety components for lifts Directive 2006/42/EC of the European Parliament and May 2006 on machinery, and amending Directive 95/16/ Directive 2000/14/EC of the European Parliament an May 2000 on the approximation of the laws of the Mem the noise emission in the environment by equipment for Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators Harmonisation t and of the Council ofeting of products, and METEd of the Council of 26f the Member States electrical equipment METEd of the Council of 26f the Member States METEd of the Council of 18 METEd of the Council of 26f the Member States METEd of the Council of 17/EC METEnd of the Council of 8mber States relating touse outdoors METE 2nd Floor, Tirana, Albania 303424/2234365

Celex Nr EuMeas Title31997L0068 Directive 97/68/EC of the European Parliament and31989L0686R December 1997 on the approximation of the laws o32014L0034 relating to measures against the emission of gase32009L0142 pollutants from internal combustion engines to be install32014L0068 machinery32010L003532014L0029 Council Directive 89/686/EEC of 21 December 198932000L0009 of the laws of the Member States relating to personal (PPE) Directive 2014/34/EU of the European Parliament a 26 February 2014 on the harmonisation of the laws o relating to equipment and protective systems intended explosive atmospheres (ATEX) Directive 2009/142/EC of the European Parliament an November 2009 relating to appliances burning gaseous Directive 2014/68/EU of the European Parliament a 15 May 2014 on the harmonisation of the laws of the M to the making available on the market of pressure equip Directive 2010/35/EU of the European Parliament and June 2010 on transportable pressure equipment Directive 2014/29/EU of the European Parliament and February 2014 on the harmonisation of the laws of relating to the making available on the market of simple Directive 2000/9/EC of the European Parliament and March 2000 relating to cableway installations designed t Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators Harmonisation of the Council of 16of the Member States eous and particulate led in non-road mobile MPWT on the approximation METE protective equipment METEand of the Council ofof the Member Statesd for use in potentiallynd of the Council of 30fuels METEand of the Council ofMember States relatingpment32010L0035 METEd of the Council of 16 METEd of the Council of 26f the Member Statespressure vessels METEd of the Council of 20to carry persons MPWT 2nd Floor, Tirana, Albania 313424/2234365

Celex Nr EuMeas Title32011R0305 Regulation (EU) No 305/2011 of the European Pa32013L0053 Council of 9 March 2011 laying down harmonised32009L0125 marketing of construction products32014L005332014L0032 Directive 2013/53/EU of the European Parliament a32014L0031 20 November 2013 on recreational craft and personal w32014L002832013L0029 Directive 2009/125/EC of the European Parliament an October 2009 establishing a framework for the s requirements for energy-related products Directive 2014/53/EU of the European Parliament and April 2014 on the harmonisation of the laws of the Mem the making available on the market of radio equip Directive 1999/5/EC (RTTE) Directive 2014/32/EU of the European Parliament and February 2014 on the harmonisation of the laws of relating to the making available on the market of m (MID) Directive 2014/31/EU of the European Parliament and February 2014 on the harmonisation of the laws of relating to the making available on the market of no instruments (NAWI) Directive 2014/28/EU of the European Parliament and February 2014 on the harmonisation of the laws of relating to the making available on the market and sup for civil uses Directive 2013/29/EU of the European Parliament a 12 June 2013 on the harmonisation of the laws of the M to the making available on the market of pyrotechnic art Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators Harmonisationarliament and of thed conditions for the MPWTand of the Council ofwatercraft METEnd of the Council of 21 METE setting of ecodesign METE METE d of the Council of 16 METEmber States relating to METE pment and repealing d of the Council of 26 f the Member Statesmeasuring instruments d of the Council of 26 f the Member Stateson-automatic weighing d of the Council of 26 f the Member Statespervision of explosivesand of the Council of MD MDMember States relating 32ticles METE 2nd Floor, Tirana, Albania3424/2234365

Celex Nr EuMeas Title31975L0324 Council Directive 75/324/EEC of 20 May 1975 on the32008L0047 laws of the Member States relating to aerosol dispenser Commission Directive 2008/47/EC of 8 April 20032003L0037 purposes of adapting to technical progress, Council Dir32007L0046 the approximation of the laws of the Member State32002L0024 dispensers32013R016832006R1907 1.4. Old approach legislation Directive 2003/37/EC of the European Parliament and May 2003 on type-approval of agricultural or forestry and interchangeable towed machinery, together components and separate technical units Directive 2007/46/EC of the European Parliament an September 2007 establishing a framework for the appro and their trailers, and of systems, components and se intended for such vehicles Directive 2002/24/EC of the European Parliament and March 2002 relating to the type-approval of two or three Regulation (EU) No 168/2013 of the European Pa Council of 15 January 2013 on the approval and marke or three-wheel vehicles and quadricycles Regulation (EC) No 1907/2006 of the European P Council of 18 December 2006 concerning the Reg Authorisation and Restriction of Chemicals (REA Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators Harmonisatione approximation of the METErs METE08 amending, for therective 75/324/EEC ones relating to aerosold of the Council of 26 tractors, their trailers with their systems, MPWTnd of the Council of 5 oval of motor vehicleseparate technical units MPWT d of the Council of 18 33e-wheel motor vehicles MPWT arliament and of the et surveillance of two- MPWTParliament and of the gistration, Evaluation,ACH), establishing a MEFWA 2nd Floor, Tirana, Albania3424/2234365

Celex Nr EuMeas Title European Chemicals Agency32008R1272 Regulation (EC) No 1272/2008 of the European P Council of 16 December 2008 on classification, labell32004L0010 substances and mixtures (CLP)32004L0009 Directive 2004/10/EC of the European Parliament and32003R2003 February 2004 on the harmonisation of laws, regulatio32004R0648 provisions relating to the application of the principle32004R0273 practice and the verification of their applications fo substances Directive 2004/9/EC of the European Parliament and February 2004 on the inspection and verification of goo (GLP) Regulation (EC) No 2003/2003 of the European P Council of 13 October 2003 relating to fertilisers Regulation (EC) No 648/2004 of the European Pa Council of 31 March 2004 on detergents Regulation (EC) No 273/2004 of the European Pa Council of 11 February 2004 on drug precursors 1.5. Procedural measures Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators HarmonisationParliament and of the MEFWA ling and packaging of METE d of the Council of 11ons and administrativees of good laboratory or tests on chemicald of the Council of 11 od laboratory practice METEParliament and of the MAFCParliament and of the METEarliament and of the MoH 2nd Floor, Tirana, Albania 343424/2234365

Celex Nr EuMeas Title3215L1535 Directive 2015/1535/EU of the European Parliament a31991L0477 September 2015 laying down a procedure for the prov32008L0051 the field of technical regulations and of rules on Inform32009L0043 repealing the Directive 98/34/EC31969L0493 Council Directive 91/477/EEC of 18 June 1991 on con31994L0011 and possession of weapons,32011R1007 Directive 2008/51/EC of the European Parliament a 21 May 2008 amending Council Directive 91/477/EE acquisition and possession of weapons Directive 2009/43/EC of the European Parliament an May 2009 simplifying terms and conditions of transfe products within the Community. Council Directive 69/493/EEC of 15 December 1969 of the laws of the Member States relating to crystal glass Directive 94/11/EC of the European Parliament and March 1994 on the approximation of the laws, regulatio provisions of the Member States relating to labelling of the main components of footwear for sale to the consum Regulation (EU) No 1007/2011 of the European P Council of 27 September 2011 on textile fibre names and marking of the fibre composition of textile products Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators Harmonisationand of the Council of 9vision of information in ation Society services METE ntrol of the acquisition MDand of the Council ofEC on control of the MDnd of the Council of 6ers of defence-related MDon the approximations METE of the Council of 23 METEons and administrativef the materials used inmerParliament and of thes and related labelling METE 2nd Floor, Tirana, Albania 353424/2234365

Celex Nr EuMeas Title32012R0286 Commission Delegated Regulation (EU) No 286/20131989L0105 amending, in order to include a new textile fibre name,32014L0060 purposes of their adaptation to technical progress, An Regulation (EU) No 1007/2011 of the European Pa Council on textile fibre names and related labelling and composition of textile products Council Directive 89/105/EEC of 21 December 1 transparency of measures regulating the prices of m human use and their inclusion in the scope of natio systems Directive 2014/60/EU of the European Parliament and May 2014 on the return of cultural objects unlawful territory of a Member State Rruga Ismail Qemali, No3, T +355 4 2273

RespAuth Suggested RespAuth/ Level of Collaborators Harmonisation12 of 27 January 2012 METE , Annex I, and, for the MOHnnexes VIII and IX to arliament and of the d marking of the fibre 1988 relating to themedicinal products foronal health insuranced of the Council of 15lly removed from the MoC 2nd Floor, Tirana, Albania 363424/2234365