SUP has formulated proposals to update the Association Agreement with the EU

In late July the Union of Ukrainian Entrepreneurs (SUP) took part in the first dialogue with the Deputy Prime Minister for European and Euro-Atlantic Integration on the renewal of the Association Agreement with the EU.

The Union, for its part, has prepared a list of proposals including:

1.  Addendum to the Association Agreement between Ukraine and the EU with a new Annex on the pharmaceutical industry which will provide full harmonization of procedures in the field of circulation, production, development and registration of medicines with EU practice. The first step should be the obligations of the parties on mutual recognition of GMP certificates.
2. Harmonization of public data on medicinal products in Ukraine with Article 21 of Directive 2001/83/EC, such as:
   – introduction of the Summary of Product Characteristics (SmPC) as mandatory for approval of the document upon registration in Ukraine. This will harmonize the package of registration documents with the requirements of most exporting countries.
   – preparation and publication for public access of Public Assessment Reports (PAR) by the State Expert Center, which will facilitate a more transparent decision-making process on the registration of medicines in Ukraine.
3.  Possibility to use reference medicines purchased in Ukraine for clinical research of bioequivalence of generic drugs planned for registration in EU countries.
4. Norms providing for deepening cooperation between the EU and Ukraine on the participation of Ukrainian producers in programs of financing the development of public health in the EU.
5.  Accelerate the signing of the ACAA Agreement (Agreement on Conformity Assessment and Acceptance of Industrial Goods) (“An industrial visa-free regime”) with the EU and expand the list of industries. Trade in goods between the parties in the sectors covered by this Agreement will be conducted on terms of trade between EU Member States.
6.  Alignment of legislation with EU legislation governing the import, production and circulation of baby food in Ukraine.
   – Development and adoption of an updated Law of Ukraine “On Baby Food” and bringing it in line with the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality” and the relevant EU Directives.
   – Alignment of the Order of the Ministry of Health of Ukraine № 696 “Hygienic requirements for baby food, safety parameters and certain indicators of their quality”, considering the Commission Delegated Regulation (EU) 2016/127 of 25 September 2015.
7.  Alignment of legislation with EU legislation governing the import, production and circulation of animal feed.
   Adoption of an analogous to a repealed bill № 3672 “On Amendments to the Final Provisions of the Law of Ukraine “On Safety and Hygiene of Feed” which will allow the use of feed additives in feed production as well as import into the customs territory of Ukraine and circulation of feed additives and feed produced using feed additives registered in the EU.
8.  Norms providing for harmonization with separate profile EU directives.