Written question asked by Christopher Chope (Conservative) on Wednesday, 2 November 2022, in the House of Commons. It was due for an answer on Monday, 7 November 2022 (named day). It was answered by Neil O'Brien (Conservative) on Monday, 7 November 2022 on behalf of the Department of Health and Social Care.
Coronavirus: Vaccination
- Question
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To ask the Secretary of State for Health and Social Care, whether there is a deadline by which the Medicines and Healthcare products Regulatory Agency is required to convert the Conditional Marketing Authorisation for the Pfizer Covid-19 vaccine for use in adults into a Full Marketing Authorisation; and whether there will be any implications for patients from a change in the status of the authorisation.
- Answer
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In general, the Conditional Marketing Authorisation (CMA) is valid for one year, where the Medicines and Healthcare products Regulatory Agency will evaluate whether the company has addressed the post-authorisation measures and CMA commitments. If this has been sufficiently addressed, the CMA can be converted to a full Marketing Authorisation (MA).
Where commitments need to be addressed, the CMA may be extended for further year before the conversion to a full MA can take place. It is not expected that there will be any major implications for patients from a change in the status of the Comirnaty vaccine’s authorisation.
Secondary information
- Type
- Written question
- Reference
- 77274
- Session
- 2022-23
- Related items
- Subjects
- Vaccination Pfizer Coronavirus
- Link
- View this Written question on www.parliament.uk
Librarians' tools
- Timestamp
- 2022-11-22 17:52:31 +0000
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- http://data.parliament.uk/writtenparliamentaryquestion/commons/2022-23/77274
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