Medicines: news on registration, pharmacovigilance and quality management in CIS

n this digest you will find the most important news on registration, safety and quality management of medicinal products in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan, which entered into force at the end of 2018 and in the first half of 2019.

 
The most significant news in brief:

In Armenia On March 30, 2019 the Decree of the Government of the Republic of Armenia No. 162-N dated February 28, 2019 “On Establishing the Procedures for State Registration, Renewal, and Variations of the Term of the Certificate of Medicinal Product in the Republic of Armenia” entered into force, which made significant changes to the registration procedures.

In Kyrgyzstan in December 2018 a new Order for the organization of a pharmacovigilance system developed in accordance with the EAEU GVP entered into force.

In March 2019 significant changes to the procedure for registering medicinal products came into force, including: issuance of an unlimited marketing authorization after renewal; the introduction of an accelerated and simplified procedure for the registration of medicinal products registered in the USA, UK, Switzerland, the European Union and Japan, as well as prequalified by WHO; simplified and accelerated registration of orphan products etc.

Also a single information system for all regulatory processes is being introduced in Kyrgyzstan, which transfers the relationship between the regulator and the medical and pharmaceutical market operators in an electronic format (online medicinal product registration system, online certification of medicinal products and medical devices, a single window for customs clearance of medicinal products and medical devices when imported).

In early April Kazakhstan introduced changes to the inspection procedure: the register of pharmaceutical inspectors of the Republic of Kazakhstan, supplemented list of documents that are attached to the Application for Inspection and specified cases of inspections.

In mid-April significant changes were made to the Rules for Medicinal Products Expert Evaluation: many paragraphs of the order were set out in a new edition. The deadline for submission of an Application for renewal was changed and amounted to 180 days before the expiration of the marketing authorization, instead of 6 months after the marketing authorization expired. At the end of May this Order was canceled.

At the end of April changes were made to the requirements for labeling and instruction for medical use: additional information was added and the requirements for documents were detailed.

In Uzbekistan at the end of October 2018 a Regulation on the procedure for recognizing the results of registration of medicinal products and substances of countries with high regulatory requirements was adopted. In mid-February 2019 the first Presidium on the recognition procedure was held and the first registrations were granted under the simplified procedure, which became evidence of the successful implementation of the recognition procedure.

In Ukraine in early April 2019 amendments to the Procedure for State Registration of Medicinal Products and a number of related legislative acts entered into force. Among the most significant changes are:

• the deadline for submitting an Application for Renewal has been changed from 90 to 180 days before the expiration of the marketing authorization (we recommend to apply for renewal in 10-12 months before the registration end date).
• the period of validity of marketing authorizations issued under the special procedure (Order No. 721 of the Ministry of Health) for the registration of medicinal products purchased by specialized international organizations has been extended by 1 year (until March 31, 2020).

In mid-July the Law “On Ensuring the Functioning of the Ukrainian Language as a State Language” entered into force, for many of which provisions transitional periods of 6 months or more have been established.

In Eurasian Economic Union till the end of May 2019 only 2 medicinal products were registered according to the unified EAEU rules, for both Kazakhstan was chosen as the reference country. In total, 68 applications for medicinal products registration are pending in the EU Unified Information System.

You can find more information about these and other changes in PDF-file.

If you have any questions – we will be glad to answer them by e-mail info@cratia.ua, by telephone +38 044 332-42-94, or at a meeting at our office.