A second revised version of the Q&A document was published on May 26, 2020. A new block of questions (sub-point 6) with six questions and answers deals with the additional temporary flexibility in the GMP/GDP area.
The following aspects are addressed:
- New/re-purposed use of premises and equipment for the production of medicinal products for the treatment of COVID-19 under limited prospective qualification and concurrent validation
- Temporary changes in quality related tasks to provide resources for the production of medicinal products to treat COVID-19
- Temporary flexibility to address shortages of imported medicinal products for the treatment of COVID-19
- Adaptations to the work of the Responsible Person (RP) with regard to travel, absenteeism and other COVID-19 restrictions
- Use of new equipment or newly authorised premises for storage and distribution of medicinal products with limited prospective qualification
Under point 2, on GMP/GDP for finished products and active ingredients, question 2.1 dealing with the rapid implementation of adaptations in the manufacturing/supply chain to ensure the supply of medicines in the EU has been revised.
In addition, a new question 2.3 has been added, which explains measures to replace on-site inspections of plasma collection centres.
The Q&A document prepared by the European Commission, the EMA and the Heads of Medicines Agencies (HMA) on the more flexible regulatory requirements during the COVID-19 pandemic will be continuously adapted (we reported). As a marketing authorisation holder you should check this page of the EMA regularly for new information.
EMA: Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic