• Service: Tax & Legal
  • Type: Publication series
  • Date: 7/1/2013

Pharma Bulletin, Issue 6, 2013 

Status of Russian drugs manufacturers could be defined from 1 January 2014

Sergey Tsyb, Director of the Department of Chemical Engineering and Bioengineering Technology of the Russian Ministry of Industry and Trade, has announced that the status of Russian goods will be approved through a Ministry of Industry and Trade order, which, it appears, will enter into force on 1 January 2014.

Currently, "Russian" drugs are recognised by changing the fourth digit in the commodity classification of the foreign economic activity code. Formally this means that a drug has received a sufficient level of processing in the country where it was released into circulation.

In practice this leads to the packaging in Russia of drugs which have been manufactured ​​abroad. We presume that the new document will require that, to receive "Russian producer" status, pharmaceutical companies will have to observe more stringent standards for manufacturing drugs in Russia.

FAS reminders on rules for placing orders to supply drugs

The FAS has informed customers, as well as those placing orders, of the coming into force from 18.04.2013 Decree of the Russian Government No. 301 of 06.04.2013 “On Establishing a Maximum Value for Initial (Maximum) Contract Prices (Lot Prices), Above Which Various Drugs with International, Non-proprietary Names Cannot Be the Subject of One Contract (One Lot), or, in the Absence of Such Non-proprietary Names, with Chemical or Generic Names”.

Thus customers, when placing orders for drugs in state tenders, shall be required to shape lots taking into account the provisions of the above decree.

Amendments to the procedure for placing orders for state tenders

Russian President Vladimir Putin has signed Federal Law No. 114-FZ dated 07.06.2013, "On Amending the Federal Law "On Placing Orders for Goods, Works and Services for State and Municipal Needs".

The amendments include entitling the parties to public and municipal contracts, civil contracts to unilaterally decline to perform a contract.

In addition, the Federal law defines the mechanism of interaction between customer and supplier on the termination of a contract due to the unilateral withdrawal by a party to execute the contract.

Information on the supplier whose contract was terminated due to a customer’s unilateral withdrawal shall be included in the register of bad-faith suppliers.

Regulation approved on licensing production and maintenance of medical equipment

The Russian Government has approved Regulation on licensing activity related to the production and technical maintenance of medical equipment. A respective resolution No. 469 dated 03.06.2013 has been signed by Prime Minister Dmitry Medvedev.

The Regulation on licensing includes:

  • licensing requirements for license applicants and for licensees
  • the list of documents the license applicant must submit to the licensing body
  • a requirement for the licensing body to place on a single state and municipal services portal information on the body’s decision to issue or renew a license.

Order on preferences for Russian producers comes into force

Russian Ministry of Economic Development Order No. 211 dated 17.04.2013“On the Conditions for Admitting Goods of Foreign Origin for the Purpose of Placing Orders for Goods for the Needs of Customers”,came into force on 16.06.2013 and will be valid until 31.12.2013.

The document stipulates that when placing orders for goods, including drugs, state tender participants shall be granted a preference in relation to the contract price of 15%, provided their application to participate in tender includes proposals to supply goods of Russian and/or Belarusian origin.

Currently this is the only legal document determining the procedure for granting preferences to domestic drug manufacturers when placing orders for state purchases.

Ministry for Healthcare reminders on current legal requirements for manufacturing drugs

On May 28 the Russian Ministry for Healthcare sent to pharmaceutical manufacturers a letter outlining the identified cases of producing drugs from pharmaceutical substances not included into the State Register of medicines subject to quality control under GOST and not under the standard documentation for drugs, which is in violation of Article 45 of Federal Law No. 61-FZ "On the Circulation of Pharmaceuticals".

In the event that a certified pharmacopeial description about a drug presumes the possibility of using pharmaceutical substances not included into the State Register of Drugs, changes must be made to the documents contained in the drug dossier.

New procedure for designating and prescribing drugs introduced from 1 July 2013

Under the Russian Ministry for Healthcare Order No. 1175n dated 20.12.2012 "On Approving the Designation and Prescribing of Drugs and Prescription Forms for Drugs, the Procedures for Creating These Forms, and Their Recording and Storage", from 1 July 2013 a new procedure will be introduced for designating and prescribing drugs.

The Order regulates the use and prescribing of drugs: when providing medical care in hospitals; when providing primary health care, emergency care and palliative care; and to citizens entitled to free or discounted prescriptions as part of their being provided primary health care.

In addition, types of prescription forms and the procedure for their creation, recording and storage have been approved. 20_12_2012.pdf





Victoria Samsonova


+7 (495) 937 44 77 (ext. 14928)