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New rules of medicinal agent registration

1 April 2015

Revera Consulting Group informs about the adopted Resolution of the Council of Ministers of the Republic of Belarus dated April 1, 2015 № 254 «On state registration (confirmation of state registration) of medicinal agents and pharmaceutical substances and On introduction of amendments and additions to the Resolution of the Council of Ministers of the Republic of Belarus dated September 2, 2008 № 1269 (hereinafter - the Resolution № 254),which establishes new rules of medicinal agent and pharmaceutical substance registration and also introduces changes in the procedure of medical products and devices registration. The adoption of this legislative act is directly related to the introduction of amendments to the Law of the Republic of Belarus dated July 20, 2006 № 161-3 "On Medicines" (hereinafter - the Law "On Medicines").

The Resolution № 254, as well as the amendments to the Law "On Medicines", enters into force on the 21th of May 2015.

1.  Medical products and devices registration

The norms, regarding medical products and devices registration, didn't undergo substantial transformation with the adoption of the Resolution № 254, but several changes nevertheless have taken place.

For reference: as amended by the Law of the Republic of Belarus dated June 18, 1993 № 2435-XII «On public health» medical products and devices form a single notion - medical products. Along with this the Resolution № 254 didn’t bring the terminology of registration rules in line with the abovementioned Law.

The rank of a complex of engineering preliminaries which precede state registration (reregistration), introduction of amendments to the registration dossier, is extended by the Resolution № 254. Therefore the complex of engineering preliminaries will include:

- a primary expertise of the documents required for state registration (reregistration), introduction of amendments to the registration dossier;
- monitoring of the production of medical products and devices;
- sanitary and hygienic investigation of the given products and devices of domestic and foreign manufacture;
- technical examination of medical products and devices of domestic manufacture;
- a specialized expertise of documents required for state registration (reregistration), introduction of amendments to the registration dossier;
- clinical trials of medical products and devices;
- other studies.

On the results of going through the complex of engineering preliminaries of the republican unitary enterprise Center for Examinations and Tests in Health Service a statement of medical products and devices safety, efficiency and quality conformance will be issued, containing examination, monitoring, test and other investigation results.

The Resolution № 254 proves the supplementary grounds for operations suspension of issued registration certificate on medical products and devices – the establishment of the fact of inadequacy in medical products quality to the stated quality in the process of their state registration, as well as delivering of negative sanitary and hygienic, technical and clinical trial results.

2. Registration of medicinal agents and pharmaceutical substances

The Resolution № 254, similar to the situation of medical products and devices, specificates the rank of the complex of engineering preliminaries. The complex of engineering preliminaries which precede state registration of medicinal agents, introduction of amendments to the registration dossier will include:

- a primary expertise of documents;
- monitoring of the medicinal agent industrial production for its conformance to the Good Industrial Practice requirements;
- approbation of the quality-control technique of a medicinal agent, as well as medicinal agent quality analysis when carrying out its clinical trial by the public health organizations;
- a specialized expertise of documents;
- research  and investigation of bioavailability (bioequivalence) of a generic medicinal agent;
- clinical trials of a medicinal agent;
- other studies.

Reregistration of medicinal agents is substituted by confirmation of registration

The Resolution № 254 following the Law № 203-3 which introduces changes in the Law "On Medicines"
stipulates simplification of administrative procedures: the procedure of reregistration of medicinal agents is substituted by the procedure of confirmation of state registration.

Currently on the results of going through the procedure of state registration of a medicinal agent a registration certificate will be issued with the term of 5 years validity. Upon the expiration of the registration certificate the medicinal agent is subject to reregistration, consequently a new registration certificate is issued for the next 5 years.

Since May 21, 2015 upon the expiration of the term of registration certificate validity in the case of a successful completion of the procedure of state registration confirmation, a registration certificate will be issued for an unlimited period of time.

Changes in pharmaceutical substances registration
Currently pharmaceutical substances are registered for the term of 5 years, and upon the expiration of the term of registration certificate validity they are subject to reregistration.

Since May 21, 2015 a registration certificate on the registered pharmaceutical substance will be issued for an unlimited period of time. In such a case it would require no completion of the procedure of state registration confirmation.

The list of grounds for introduction of amendments to the registration dossier is stated

Currently the grounds for introduction of amendments to the registration dossier are contained only in the list of administrative procedures. The Resolution № 254 states the exhaustive list of the grounds for introduction of amendments to the registration dossier in the text of the Regulation on state registration (confirmation of state registration) of medicinal agents and pharmaceutical substances.

Situations, which are the grounds for state reregistration, after the entrance of the Resolution № 254 into force, will become the grounds for introduction of amendments to the registration dossier.

We would remind that the reregistration grounds currently are the cases of medicinal agent name changes, reorganization or manufacturer name changes and changes of a pharmaceutical manufacturer (manufacturing country).

3. The State Register of medicinal agents of the Republic of Belarus

The Resolution № 254 probates the Regulations for the structure, the procedure of formation and maintenance of the State Register of medicinal agents of the Republic of Belarus.

The State Register can be found on the official websites of the Ministry of Health and the republican unitary enterprise Center for Examinations and Tests in Health Service. The Regulations determines the list of information, which is to be included on the State Register and to which posted prices are also related.

We would remind that the Law № 203-3introduces the obligationof applicantswhen applying for state registration of medicinal agents to note inthe documentsformingthe registration dossier the maximum sale price of the medicinal agent. This maximum sale price must becomparable toselling pricesin the country of medicinal agent manufacture - the member states ofthe Eurasian Economic Unionas well as in othercontiguouswith the Republic of Belarus countries - if the medicinal agent is registered in these countries.

Remark

The amendments and additions established by the Resolution № 254 are focused in general on bringing the registration rules in line with the norms of the Law № 203-З introducing amendments to the Law "On Medicines".

Since May 21, 2015 medicinal agents will be registered for the term of 5 years, upon the expiration of the stipulated term medicinal agents will go through the procedure of state registration confirmation. Registration certificates on pharmaceutical substances already when applying for registration will be issued for an unlimited period of time. At the same time medical products and devices are still subject to the procedure of its reregistration.

But despite quite a detailed regulation of the registration procedure, the Resolution № 254 did not provide an answer to the question: how the price should be noted when applying for state registration of a medicinal agent.

How we can assist

Revera Consulting Group experts on a regular basis monitor all the legislative amendments in the sphere of pharmaceutical activities and they are prepared to render legal assistance to all the participants of the pharmaceutical market: from manufacturers to pharmacy chains.
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