The procedure of transfer of the registration certificate of medicine isn't established by the Russian legislation. However, it doesn’t mean that the transfer is forbidden.
The list of documents that make up the registration dossier of medicine is defined in part 3 Article 18 of the Federal Law № 61 dated 12.04.2010 “On Circulation of Medicines" (hereinafter - the Law № 61). Article 30 of the Federal Law № 61 establishes the bases of amending the documents contained in the registration dossier, as well as the procedure for making such changes. The order of the Ministry of Health and Social Development of the Russian Federation No. 760n dated 26.08.2010 approved the formof "Application of statements for modification of the documents in the registration file on the registered medicine for a medical application".In addition, the Order of Ministry of health of the Russian Federation of 22.10.2012 No. 428n approved the "Administrative regulations of the Ministry of health of the Russian Federation on provision of state service for state registration of medicinal products for medical use", which, in particular, provides a procedure for amendments to documents contained in registration dossier for registered medicines.The change of the applicant in the registration file of medicines isn't provided in all, the listed above, regulatory legal acts.
The draft of the Order of the Ministry of Health of the Russian Federation "About approval of classification of the changes brought in the documents containing in the registration file on the registered medicine" now is in consideration at a stage of independent anti-corruption examination (on 28.10.16).This project was created on February, 2015 and undergone some changes since that time. The draft, posted on the website www.regulation.gov.ru contains classification changes, including the basis of the "change of owner or holder of the registration certificate". The examination for such changes is not required. In a note to such change provided that it is associated with the transfer of the rights to the drug. The annotation to such change specifies that it is connected with assignment of rights on the medicine.
While transferring the registration certificate it must be considered that it transfers the responsibility for the quality, efficacy and safety of drugs (pharmacovigilance).At the same time the holder of the registration certificate can transfer the rights of conducting activities for pharmacovigilance ofthe drug to the other organization without transferring the registration certificate.In this case, the holder of the registration certificate is obliged to make a written agreement with the organization specifying the format; time limits; the ways of communication in pharmacovigilance; the organization responsible for the provision of data.The holder of the marketing authorization must inform in writingRoszdravnadzorabout the conclusion of contractual agreements for the exchange of data on pharmacovigilance.
Transfer of the registration certificate according to the foreign legislation
In the EU marketing authorization holder, as well as in Russia, is responsible for pharmacovigilance of the drug, which he places on the market. Procedure for transfer of the registration certificate varies depending on the country - sometimes it can take only a simple supply cover letter, somewhere - completely new design of the registration certificate.
In the EU the procedure of the transfer of the registration certificate of the drug is regulated by the Regulations of the Commission of the EU No. 1234/2008 and also by the Directive 2001/82.Almost every country of the EU has also the normative document that establishes the competent authority for making this change and the whole application procedure.The choice of the competent authority for changes depends on how the medicine was registered according to the centralized procedure by European medicines Agency or under the national, decentralized or mutual recognition procedure, i.e. by the national agencies of member countries of the EU.
In case of centralized registration, the current holder of the registration certificate holder and proposed holder jointly make a statement with a request to amend. The package of introduced documents is quite large and includes, for example, the cover letter of the drug data; a document certifying that the proposed holder meets all requirements of the current holder; document recording the absence of any other of the changes; documents of registration of the proposed holder within the EU, etc. It provides 30 days for changes plus additional time for publication.
In the UK, this procedure is legally not fixed, however, despite this there are special forms of documents for such changes.The documents are introduced by the expected new holder. In addition to the standard documents you must provide a letter from the manufacturer that he will continue to be engaged in the production with the new holder of the registration certificate. In case of refusal, this producer needs to be excluded from documents. The term of consideration of the application is up to 42 days.
In the countries of Latin America it is impossible to make changes to the registration dossier in case of changing the holder. For this purpose it is necessary to arrange completely the new registration certificate. The procedure can occupy more than one year.
One of the most important aspects in the transfer of the rights to the drug in foreign countries is a grace period, i.e. the period during which the original holder of the registration certificate will be able to profit from the drug, produced before his license will be fully switched to the new holder.For example, Albania has no such grace period - as soon as the transfer of the registration certificate is confirmed by the authorized body, all the rights are transferred. Some companies issue more drugs before the confirmation of transition of the right for receipt of benefit, others in advance – agree with national authorities about provision of a grace period.
There is a special system of the grace period in the UK. The date of transition of all rights to the drug is established by the initial holder, but can't exceed 6 months from approval date of change of the registration certificate. Thus, during this time the market has two holder of the registration certificate, and the original holder gets a profit from the sale of LP.
Thus, the procedure of amending registration dossiers associated with the change of the holder or owner varies from country to country. Today in Russia such change is not legally stipulated, however, the order of Ministry of health of the Russian Federation, which contains this base change,will soon be adopted.
The article was prepared 1/11/2016
by Maria Nikitina, junior associate of the Law firm «BRACE»