28/29 September 2021
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic.
After the first revision, which was published on 17 April 2020, a second update has now been released. Question 2.3 and section 6 have been added and the answer to question 2.1 has been updated.
Concerning GDP, section 6 is of particular interest. Question 6.1 points out that "in case national legislation in EEA member states already provides legal tools for such extraordinary situations, these national tools need to be triggered before applying parts of the proposed measures." Question 6.2 to 6.4 deals with GMP flexibilities. In Questions 6.5 to 6.7, GDP related topics are discussed.
Questions 6.5 addresses adaptations to the work of the Responsible Person (RP) considering travelling, absenteeism and other restrictions arising from COVID-19 pandemic. Particular attention is given to the topics of remote working of the RP, the delegation of duties and responsibilities of an RP to another RP or to a person who is not an RP as well as replacement of the RP at short notice. On this last point, the document states: "It is recognised that under exceptional circumstances, like quarantine measures travel restrictions or longer absence due to sickness, it may become necessary to replace the RP at short notice. Agreement of the National Competent Authority should be sought in advance for replacement of the designated RP by an employee with appropriate competence, experience, knowledge and training in GDP or a third party RP".
Question 6.6 says that it might be allowed to use new equipment or newly authorised premises for storage and distribution with limited prospective qualification. It is pointed out that "agreement of the National Competent Authority should be sought before using any new premises for wholesaling activities" and that "the full qualification and validation should be completed without delay following as soon as possible."
Finally, question 6.7 deals with whether so-called planned deviations from normal practice (temporary change controls) are permitted. The answer states that this is possible, provided that it is "documented within the quality system, approved by the RP and assessed on a case by case basis in accordance with a quality risk management process."
Please also see the complete Q&A document entitled QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC.