The question and answer document is the first in a series of guidances and follows a notice sent earlier this month to MAHs to begin preparations for Brexit. Outlined below are some of the sections and what companies can expect.
Sponsor of an Orphan Medicinal Product Designation
The Q&A says that such a sponsor will “need to transfer its designation to a holder established” in the European Economic Area (EEA), “or it will need to change its place of establishment to a Member State of the Union (or EEA) and submit the corresponding documentation through a change of name and/or address of the orphan designation holder procedure provided the legal entity remains the same.”
**Qualified Person for Pharmacovigilance (QPPV) **
The QPPV “must reside and carry out his/her tasks” in the EEA, the Q&A says. But the guidance notes that changes in the QPPV, including contact details (telephone and fax numbers, postal address and email address) may, for medicinal products for human use, be updated through the Article 57 database only (without the need for a variation).”
**Pharmacovigilance System Master File (PSMF) **
Another change that MAHs can make through the Article 57 database is the location of the PSMF to within the EEA. According to Commission Implementing Regulation (EU) No 520/2012, the PSMF must be located within the EEA.
Batch Release
And the qualified person of the manufacturing and importation authorization holder is responsible to certify that each batch of medicinal product intended to be placed on the EEA market was manufactured in accordance with EU good manufacturing practice requirements and the marketing authorization. For centrally authorized medicinal products, the guidance says the MAH will need to transfer its current UK-based site of batch release to a location established in the EEA and submit the corresponding variation.
Others
Other questions deal with manufacturing sites of active substances and finished products located in the UK, and whether companies will still have access to financial and administrative assistance in accordance with Commission Regulation (EC) No 2049/2005, also known as the “SME Regulation.”
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