The Ministry of health of Russia has developed amendments to the application form on amendments to the documents contained in registration dossier for registered... The Ministry of health has prepared amendments to the documents contained in registration dossier for the medicinal product

The Ministry of health of Russia has developed amendments to the application form on amendments to the documents contained in registration dossier for registered medicinal product for medical use, approved by order of Ministry of health of Russia from September 21, 2016 number 727н.

The draft order prepared to implement provisions of the Federal law from December 28, 2017. No. 425-FZ “On amendments to the Federal law “On circulation of medicines”, which provides an indication in the state register of medicinal products for medical use information:

– registration the owner or holder of the registration certificate for the medicinal product for medical use as a taxpayer in the country of registration (for Russian legal entities – taxpayer identification number (TIN) for foreign legal persons – country of registration, name of registering authority, registration number, taxpayer ID in the country of registration (incorporation) or its equivalent);

– on the registration of the manufacturer of the medicinal product for medical use as a taxpayer in the country of registration (for Russian legal entities – taxpayer identification number (TIN) for foreign legal persons – country of registration, name of registering authority, registration number, taxpayer ID in the country of registration (incorporation) or its analogue).

In this regard, the application form is supplemented with relevant fields to fill when applying for amending to the documents contained in registration dossier for registered medicinal product for medical use.

The holders or owners of certificates of registration of medicinal products, manufacturers of medicines registered prior to the date of entry into force of Law No. 425-FZ, shall send information about registering as a taxpayer in the country of registration (for Russian legal entities – taxpayer identification number (TIN) for foreign legal persons – country of registration, name of registering authority, registration number, taxpayer ID in the country of registration (incorporation) or its equivalent) in the Ministry of health of Russia until January 1, 2019 (part 3 of article 2 of Law No. 425-FZ).

It is planned that the document will come into force in October 2018

Public discussion of the draft order will be carried out on the website regulation.gov.ru until 14 August 2018.

No comments so far.

Be first to leave comment below.

Your email address will not be published. Required fields are marked *