From 1 July 2015, entered into force amendments to the Federal law No. 61-F3 «On circulation of medicines» dated 12.04.2010 year is the most significant recent changes in the law, they aimed to concretize the concepts and elimination of the defects that existed previously. Especially, it has affected the area of quality control of drug production.
Information would be of interest to medical representatives or job seekers.
the key changes include:
- the Approval status of the owner of the registration certificate;
- Introduction to GMP certificates;
- Defined new deadlines for registration of drugs, in particular it touched generics:
- registration of generic drugs available on the expiry of 6 years after the protection of clinical trial results;
- Express registration is available for up to 3 generics;
- you entered the registration dossier;
- the Introduction of new rules of registration and calculation of selling prices for essential medicines;
- To cancel the registration of medicines now additional grounds, introduces the audit and control the production and trafficking of drugs.
Certainly, the introduction of new amendments to the law affected the specialists on drug registration.
in Addition to the mandatory availability of higher pharmaceutical or medical education, knowledge of the basics of current legislation and requirements to medicines, specialists put forward additional requirements:
- Specialists must have experience in monitoring the safety and effectiveness of drugs, constant monitoring and reporting to be sent to state authorities for control at intervals established by the law (every 6 months for two years after registration of the drug in the future in the next 5 years). Since the failure or mistakes when creating such reports may result in cancellation of registration of the drug which is imposed by the Ministry of Health of the Russian Federation.
- GMP certificates were introduced from 01.01.2014, but in practice has not worked, because in Russia there is no confirmation of GMP standards. With 01.07.2015 year, the situation will change dramatically and the Ministry of Health will issue a written opinion on the conformity of the manufacturer manufacturing practice requirements. Therefore, the candidate should know the whole mechanism of obtaining the GMP certificate and the requirements for drug products in accordance with it.
- changes Were made to the new format of the registration dossier. Now, the experts on drug registration, you must know how to compile a dossier for the registration of drugs under the new standard, including the common technical document, chemical, pharmaceutical and biological documentation. To be able to detail the requirements for the content of each section and instructions for use, which significantly differs from the previously existing requirements.
the New amendments directly affect all types of pharmacological activity, down to medical representatives. Change the specificity of recruitment, eligibility requirements and evaluation criteria for successful professionals.
If earlier it was enough to find a specialist with higher pharmaceutical or medical background who has had experience in drug registration, the candidate will be targeted. Will need to look for a candidate who has an understanding of GMP certification, working experience with a new form of the dossier, understanding of new requirements for drug registration, experience in the control of the safety and efficacy of drugs.
of Course, requirements will complicate the task in the selection of candidates for registration of medicines. But we must understand that all these requirements are not just so, and buying the drug at the pharmacy we, ordinary consumers will have the confidence that the drug has passed all the stages of registration, verified and safe.
Branicevo Tatiana,
The recruiter,
Recruiting company AVICONN
