Sub-areas within the chapter 1:
1. General Principles
Montenegro will review the state of play in its legislation and established procedures, having in mind that the main provisions of the TFEU („general principles“) are outlined as follows:
– Article 34 is applicable for the import within the EU and prohibits „quantitative restrictions and all measures with an equal effect“ between the Member States;
– Article 35 is applicable for export form one EU Member State to another and also prohibits „qualitative restrictions and all measures with an equal effect“;
– Article 36 which provides derogations form the freedom of the internal market in accordance with articles 34 and 35, and which are justified on an individual legal basis.
In addition, there are also national non-harmonized technical regulations in this section which can represent potential obstacles to free trade. It is very important that all applicable regulations are entered in the appropriate registers and that there is a systematic plan for monitoring.
Nevertheless, there are also national non-harmonised technical regulations in this area that may represent potential obstacles to free trade. It is very important that all applicable regulations are placed in the appropriate registers and that there is a systematic plan for monitoring those regulations.
2. Horizontal measures
Horizontal legislation prescribes horizontal measures which are uniformly implemented in technical requirements wherever it is applicable. The coordinating body in charged for the activities within the quality infrastructure is the Ministry of Economy. In addition, the competent authorities (ministries) have legislative framework (model in case of specific laws) for proposing (Decrees or Laws) or adopting (Rulebooks) technical regulations which are transposing the EU acquis related to products within their competences. Furthermore, it was developed a model for appointment (“new approach”) and authorisation (“old approach) of bodies for conformity assessment, which emphasises the differences between the responsibility of the State – “Old approach” and manufacturers’ obligations – “New approach”.
There are four subareas identified within the Horizontal measures: Standardisation, Metrology, Accreditation and Market Surveillance which includes the work of the Coordination Body for market surveillance.
3. Vertical measures
Vertical measures imply harmonisation with the EU acquis which is divided on directives of New Approach and directives of Old Approach.
Within the so called “New Approach”, the basic principle refers to manufacturers’ (with the support of other business entities) complete responsibility for conformity and safety of products which will be placed on the market. Harmonisation of the Montenegrin legislation with the EU acquis in this area is related to: low voltage electrical equipment, lifts, electromagnetic compatibility, simple pressure bowls, pressure equipment, gas devices and hot water boilers, aerosols dispensers, machines safety, ATEX – equipment and protective system for use in potentially explosive environment, personal protection equipment, measuring instruments, non-automatic devices and equipment for measuring weight, eco-design of products affecting the energy consumption, toy safety, medical devices, cableways, recreational crafts, construction products, noise emission of machines used outdoors, explosives for civil use, pyrotechnics, as well as radio and telecommunications terminal equipment.
When it comes to the “Old Approach”, the state is responsible for safety of products and it carries out activities related to creating and granting authority to the appropriate state bodies for conducting conformity assessment (registration, assessment and approval). This approach includes following areas: textile, footwear, crystal glass, measurement units, pre-packaged products, bottles as measurement bowls, precursors for narcotics, cosmetic products, pharmaceutical products (medicinal products for human use and medicinal products for veterinary use), artificial fertilizers, chemicals, biocides and motor vehicles.
4. Procedural measures
Procedural measures include notification of regulations, procedures for conformity assessment and information society services related to the directive 98/34/EC; checks at the external borders, acquisition and possession of weapons; quantitative restrictions and cultural goods.
Montenegro should also demonstrate that it has enough administrative capacities for the adequate implementation of the legislation in the chapter 1. In that regard, relevant authorities are continuously working on strengthening their administrative capacities so that, once Montenegro becomes the EU Member State, demonstrate they have efficient and professional structure for implementation of the legislation.
When was the chapter opened?
Montenegro opened Chapter 1 – Free movement of goods on 20 June 2017 at the Intergovernmental Conference which took place in Luxembourg. In order to keep up with challenges within the negotiation process, the Government of Montenegro adopted on 26 July 2018 new Decision on establishment of the Working group for preparing and conducting negotiations on Montenegro’s accession to the European Union for the area of the EU acquis which relates to the chapter 1 – Free movement of goods.
Within the chapter 1 Montenegro has to meet 4 closing benchmarks:
1. Montenegro adopts and puts in force legislation transposing Directive 2001/83/EC on the community code relating to medicinal products for human use as amended by Directive 2004/27/EC and legislation transposing Directive 2001/82/EC relating to medicinal products for veterinary use – this includes establishing the authorisation process for medicinal products in both fields -, as well as Directive 89/105/EC relating to the pricing and reimbursement of pharmaceutical products, in line with the principles of the jurisprudence of the European Court of Justice
2. Montenegro continues to make progress towards alignment of horizontal legislation with the acquis and demonstrates good progress towards transposition of the New, Global, and Old Approach product acquis particularly in those sectors where alignment is so far insufficient or limited.
3. Montenegro continues to make progress towards completing the introduction of mutual recognition clauses, and the necessary amendments to domestic legislation and administrative practices in order to comply with Articles 34-36 TFEU.
4. Montenegro demonstrates that it has the adequate administrative capacity to properly implement and enforce the legislation in all horizontal areas affecting the free movement of goods (regulatory, standardisation, accreditation, metrology, conformity assessment and market surveillance) as well as legislation transposing New, Global, and Old Approach product acquis, by the time of accession.
Institutions/organizations participating in the negotiation group?
Negotiator for the Chapter 1 and Chief of the Working group are appointed by the Ministry of Economy. Contact person for the chapter 1 is appointed by the Office for European Integration.
Members of the Working group for chapter 1 are representatives of the following institutions/organisations: Ministry of Economy, Office for European Integration, Agency for medicinal products and medical devices, Bureau of Metrology, Accreditation Body of Montenegro, Institute for Standardisation of Montenegro, Faculty of Mechanical Engineering (University of Montenegro), Ministry of Health, Ministry of Interior, Faculty of Economics (University of Montenegro), Administration for Inspection Affairs, Chamber of Economy of Montenegro, Ministry of Transport and Maritime Affairs, Customs Administration, Parliament of Montenegro, NGO “Ecological Movement – Ozon”, Electrical Engineering Chamber, Directorate for Foodsafety, Veterinary and Phytosanitary Affairs, Montenegrin Employers Federation, Ministry of Sustainable Development and Tourism, Eco-toxicological Examination Centre and Ministry of Culture.
What is the benefit for Montenegro of this chapter?
Harmonisation of the Montenegrin legislation with the EU acquis in the chapter 1 will enable export of Montenegrin products on the EU market. By becoming the EU Member State, Montenegro will be an integral part of the single market where all the Member States apply the same rules. In that regard, it will be ensured higher level of quality not only for foreign products which will be placed on the internal market, but also for Montenegrin products. In that sense, higher level of quality will create opportunity for Montenegrin products to be more competitive at the EU market.