License Conditions for the Import of Medicinal Products:Updated Edition Pending!

On the 12th of February Ukraine's Ministry of Health published the draft resolution of the Cabinet of Ministers "On Approval of the License Conditions of the Business of Drug Manufacturing, Wholesale and Retail Drugs, Importing Drugs (Except Active Pharmaceutical Ingredients)" (hereinafter - the draft regulations). It is to be noted that the need for new licensing conditions arose due to the Law of Ukraine № 222, dating from 02.03.2015 "On Licensing of Economic Activity" under which the licensing conditions have to be approved by the Government and not by the order of the Ministry.

It is underlined that a draft resolution of a similiar content, prepared by the State Administration of Ukraine on Medicinal Products, had been put before public discussion on the 25th January this year. The draft resolution prepared by the Ministry of Health of Ukraine , does not contain any significant differences , except for some editorial amendments.

Nevertheless, the draft resolution of the Ministry of Health envisaged an important provision, under which the entry into force of certain items was postponed until 1st of March 2018. In particular, these provisions concern:

• The licensee making the relevant contract(s) (the contract(s) with a foreign manufacturer and / or supplier of this drug, and/or registration certificate holder for this medicinal product ( paragraph 10 section 6);

• The licensee's obligation to implement and maintain the functioning of the pharmaceutical quality system , including good manufacturing practices , good practices of distribution, proper storage practices and quality risk management (paragraph 11 section 6 );
• The obligation of the manufacturer and /or importer to conduct further testing of the stability of the medicinal product after its arrival on the market, which should be reflected in the relevant agreement on a mandatory basis ( subparagraph . 12, paragraph 16 , section 6 );

• Concerning duties under the draft regulation of the customer and the contractor in carrying out external (outsourcing) activities (paragraph 17 section 6)

• Storage and archival control samples ( paragraph 21 section 6).

It is to be recalled that in their time some of the provisions were "the bone of contention" between the regulator and the subjects of the pharmaceutical market.

For example, the presently effective Licensing conditions for the business of importing drugs approved by order № 143 of the Ministry of Health of Ukraine, dating from 20.02.2013 (hereinafter - "the order № 143") provides provisions under which the import of medicines should be conducted by a licensee under the contract (agreement) concluded with the foreign manufacturer or supplier of the drug and the owner of the registration certificate for it. The matter concerns a three-way contract, the requirement for the conclusion of which seems by importers to not be feasible. Moreover, the abovementioned provision under order №143 is to come into force on the 1st March this year.

Therefore a situation may arise where the abovementioned provisions will be in force before the relevant decision of the Cabinet of Ministers' of Ukraine albeit with the edition of order № 143.