Get the free Marketing Authorisation for a Parallel Import (MAPI) - vmd defra gov
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This document serves as an application for marketing authorisation for a parallel import of veterinary medicines in the UK, detailing necessary particulars about the product, manufacturer, and required
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How to fill out marketing authorisation for a
How to fill out Marketing Authorisation for a Parallel Import (MAPI)
01
Obtain a copy of the Marketing Authorisation Application (MAA) form for Parallel Import (MAPI).
02
Gather required documentation, including proof of the original medicinal product's authorisation in the reference country.
03
Fill in the MAPI form with details about the parallel imported product, such as its composition, strength, and packaging.
04
Provide information on the manufacturer of the imported product and the country of origin.
05
Include a declaration that the parallel import is not intended to infringe any patent rights.
06
Submit the completed application along with all supporting documents to the relevant regulatory authority.
07
Pay any applicable fees for the application process.
08
Respond promptly to any queries or requests for additional information from the regulatory authority.
Who needs Marketing Authorisation for a Parallel Import (MAPI)?
01
Pharmaceutical companies or importers wishing to bring a parallel imported medicinal product into the market.
02
Entities looking to market a version of an existing drug that has already been authorised in another country.
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What is Marketing Authorisation for a Parallel Import (MAPI)?
Marketing Authorisation for a Parallel Import (MAPI) is a regulatory approval that allows the importation and sale of a pharmaceutical product in a country, which has been marketed lawfully in another country within the European Economic Area (EEA) without the need for a new clinical trial.
Who is required to file Marketing Authorisation for a Parallel Import (MAPI)?
Any company or entity that intends to import and distribute a parallel import version of a medicine in a particular country is required to file for Marketing Authorisation for a Parallel Import (MAPI). This typically includes pharmaceutical importers and wholesalers.
How to fill out Marketing Authorisation for a Parallel Import (MAPI)?
To fill out MAPI, an applicant must provide specific details about the medicine, such as its brand name, the country of origin, the marketing authorization number from the original product, packaging details, and evidence of compliance with regulatory standards in both the exporting and importing countries.
What is the purpose of Marketing Authorisation for a Parallel Import (MAPI)?
The purpose of MAPI is to ensure that parallel imports of pharmaceutical products meet the legal, safety, and quality standards required in the importing country while promoting competition and making medicines more accessible to consumers.
What information must be reported on Marketing Authorisation for a Parallel Import (MAPI)?
The information that must be reported includes the product's name, composition, manufacturing details, the authorization number from the original marketing authorisation, pricing information, and documentation proving the product's compliance with health and safety regulations.
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