In this issue:
- Pharmaceuticals packaged in Russia Federation qualify for “made in Russia” products till the end of 2015
- Regulation adopted on approval for import of pharmaceuticals intended for humanitary aid
- EAEC Rules for pharmaceuticals registration and expert examination developed
- Licensing procedures for the pharmaceutical activity are specified
- Draft law submitted to the State Duma on termination of licenses of pharmacies that sell Rx drugs without a prescription
Pharmaceuticals packaged in Russia Federation qualify for “made in Russia” products till the end of 2015
The Draft Government Resolution “On Amendments to the Government Resolution #719 dd. July 17, 2015 “On Criteria for Classifying Products as Industrial Products Having no Analogues Produced in the Russian Federation”, placed by the Ministry for Industry and Trade, has passed public debates.
The proposed amendments introduce a number of criteria for each type of medical devices and pharmaceuticals to qualify them for products originating from Russia.
In particular, pharmaceuticals registered in Russia (including sera and vaccines) shall be deemed as Russia-manufactured products under the following conditions:
- till December 31, 2015: if the finished drug form production or packaging are done in the territory of the EuroAsian Economic Community,
- starting from January 1, 2016: if both the finished drug form production and packaging are done in Russia.
The Resolution is expected to come into force on October 1, 2015.
Regulation adopted on approval for import of pharmaceuticals intended for humanitary aid
The Order of the Ministry of Healthcare #408n dd. July 2, 2015 approves the Administrative Regulation on Rendering the State Service of Issuance of an Approval for Importing into Russia Pharmaceuticals for the Purposes of Humanitary Aid or Emergency Aid.
The Regulation establishes timeline and sequence of administrative procedures performed at the applicant’s request, as well as the procedure of coordination between the Ministry’s departments and the applicants and other public authorities in course of the state service rendering.
The said state services are free of charge.
The state service shall be rendered within 10 business days maximum from the date of receiving the applicant’s documents by the Ministry of Healthcare.
EAEC Rules for pharmaceuticals registration and expert examination developed
The EuroAsian Economic Commission’s working group responsible for formation of general approaches to regulation of pharmaceuticals circulation in the EuroAsian Economic Community (EAEC) has developed the Draft Rules for registration and expert examination of pharmaceuticals for medical use.
The document is essential to create the EAEC common market of pharmaceuticals, which is supposed to start functioning from January 1, 2016. Starting from this date, all the safe, effective and high-quality pharmaceuticals should freely circulate within the Community.
The Rules contain detailed requirements to:
- submission of applications for pharmaceuticals registration;
- format and content of the registration dossier for particular pharmaceuticals groups.
The draft Rules are posted on the websites of the EAEC and the Commission for the public debates.
Licensing procedures for the pharmaceutical activity are specified
The Order of the Ministry of Healthcare Order #419n dd. July 7, 2015 “On Adopting the Administrative Regulation on Rendering the State Service on Licensing Pharmaceutical Activity (except for Activities Carried out by Wholesalers of Pharmaceutical for Medical Use and Pharmacies Governed By Federal Executive Bodies and State Academies of Sciences) by Regional Executive Bodies” is registered with the Ministry of Justice of Russia on August 11, 2015 with number 38460 assigned.
According to the Regulation, regional executive bodies shall perform licensing for the following types of pharmaceutical activities:
- retail trade, manufacturing, distribution, storage and transportation of pharmaceuticals for medical use;
- storage and transportation of pharmaceuticals for medical use.
The Regulation envisages, in particular:
- requirements to the rules of informing on the state service rendering;
- prohibition to request from an applicant any actions and applications related to obtaining approvals from other federal executive bodies (the Federal Tax Service of Russia, the Federal Service for State Registration, the Federal Service for Consumers’ Rights Protection and Human Welfare);
- timeframe for the state service rendering;
- a closed list of documents required for the state service rendering;
- the list of administrative procedures;
- forms of control over the state service rendering;
- pre-court procedure of appealing against the licensing body’s and officials’ actions and decisions.
Draft law submitted to the State Duma on termination of licenses of pharmacies that sell Rx drugs without a prescription
National Assembly of Karachaevo-Cherkessia Republic initiated tightening of regulatory sanctions for licensing rules breach. The Draft Federal Law “On Amendments to the Code of Administrative Offences of the Russian Federation and Article 14 of the Federal Law “On Licensing of Certain Types of Activities” proposes to introduce a new type of liability into the Russian Code of Administrative Offences – removal of a pharmaceuticals license in cases of:
- repeated carrying out of business activity with gross violation of the license terms,
- repeated carrying out of non-for-profits activity with gross violation of terms and requirements of the corresponding permit (license), if such a permit (a license) is mandatory.
Upon the approval by the Parliament, the law will come into force on January 1, 2016.
The list of foreign-manufactured medical devices restricted from access to public procurement to be extended
On August 3, the Ministry for Industry and Trade placed for public debates the Draft Government Resolution “On Amendments to the Government Resolution #102 dd. February 5, 2015”.
The Draft Resolution envisages the following:
- prohibition to include into the same lot the medical devices which are included and are not included into the List of types of medical devices originating from foreign states (other than the Republic of Armenia, the Republic of Belarus and the Republic of Kazakhstan) restricted from access to the state and municipal procurements, approved by the Government Resolution #102 dd. February 5,2015.
- The proposal to supplement the List by classification codes according to All-Russian Product Classifier OK 034-2007 and medical devices types denominations.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.