Circulation of medicines: regulatory amendments

30.12.2014

Legal Update No. 487

Goltsblat BLP advises that major amendments, to the regulation of medicine circulation have been introduced, both locally and at the interstate level.

The Russian Legislation

At the regulation level in Russia, Federal Law No. 429-FZ of 22 December 2014 has introduced major amendments into the Federal Law "On Circulation of Medicines" passed back in 2011. The changes are aimed at lowering administrative barriers on the medicine market, adjusting pricing of medicines included into the essential medicine list (the "EML"), cultivating competition in the industry and promoting launch of a large number of substitutes on to the market.

The most high-profile matters covered by the amendments are:

  • Establishment of clear set of criteria for deciding whether medicines are substitutable, providing the FAS Russia with a very convenient tool for use during antitrust investigations;
  • Determination of the legal framework for biotechnological medications circulation;
  • Permissibility of clinical trials performance independently from the medicine registration procedure;
  • Obligation of medicine registration certificates holders to provide generic manufacturers, with samples of reference medicines for conducting clinical trials, for a consideration;
  • Manufacturers of generic medicines may now apply for state registration four years after state registration of the reference (original) medicines and manufacturers of biosimilars – three years after state registration of the reference medicines;
  • Introduction of fast-track examination for orphan medicines, the first three generics and medicines for minors.

Moreover, attempts have been made to control online sales of medicinal products. The authorities have been granted with a number of new powers to control the industry, such as the right to block websites offering distant sales/delivery of medicines without going to court.

Certain provisions of the new law will be further clarified and elaborated by subordinate regulations issued by the Government and ministries.

The major set of amendments is expected to enter into force on 1 July 2015. Apart from that later effective dates are specified for particular amendments, for instance, the procedure for organising and performing an inspection of how entities involved in medicine circulation observe good laboratory practice (GLP) comes into effect on 1 January 2016.

Interstate Agreement

At the interstate level, an Agreement has been signed on the General conditions for medicine circulation within the Eurasian Economic Union (the "EEU").

The Russian Federation, Belarus and Kazakhstan declared development of a common market for medicines in compliance with good pharmaceutical practices and pursue a coordinated medicine circulation policy.

The member states have agreed to:

  • Circulate medicines registered in the manner established by the EEU Commission within all the member states;
  • Develop unified lists of EEU registered medicines and medicine circulation information databases;
  • Cooperate in identifying falsified medicines;
  • Consistently harmonise the (general and specific) pharmacopoeia clauses of the members states’ official pharmacopoeias;
  • Align procedures for conducting pre-clinical and clinical trials (tests) of medicines in the member states with the general rules of GLP and GCP (good clinical practice) and requirements on conducting trials (tests) of medicines approved by the Commission.

In order to apply general approaches in practice, the EEC plans to adopt more than 40 documents aimed at harmonise regulatory standards and rules in the member states. These documents will include Rules for Good Pharmacovigilance Practice, Rules of GCP, requirements on medicine labelling and rules for pharmaceutical inspections checking compliance with the general manufacturing practice (GMP) rules.

The Agreement is expected to come into force on 1 January 2016 but it might be postponed, depending on whether or not the member states observe the ratification procedures.

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