Coronavirus: consequences for applications for production and distribution licences, GMP inspections and certificates
Unfortunately, the current coronavirus situation is also having consequences for applications for licences for the manufacture and distribution of veterinary medicinal products and for the execution of GMP inspections at the production locations of veterinary medicinal products.
Company visits by the Veterinary Medicinal Products Unit
Since March 2020 the Veterinary Medicinal Products Unit (Bureau Diergeneesmiddelen, BD) has not carried out any company visits in conjunction with an application or amendment for wholesale and retail licences. However, applications are being processed and, where possible, assessed remotely. BD assesses the process per application and informs applicants by email. The BD issues wholesale and retail licences after the assessment and if the licence requirements are fulfilled. Company visits will then be scheduled at a time yet to be determined.
GMP certificates for production and import licences
In March 2020 the Healthcare and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) announced that, for the time being, it would not be carrying out any GMP inspections, either within the EU or elsewhere. This also applies for veterinary GMP inspections which the IGJ is commissioned to carry out by the BD. The IGJ can only carry out a GMP inspection in urgent situations and in consultation with the BD.
For the time being GMP certificates of manufacturers of veterinary medicinal products are being extended until the end of December 2021 (see also the information in EudraGMP). In this respect the BD is following the advice of the IGJ as well as the policy of the European Medicines Agency (EMA).
Any exceptions to this temporary extension may, for example, be GMP certificates whereby a new time period is indicated in the comments, or whereby changes have been made to the scope of the GMP certificate (for example new buildings or new veterinary medicinal products).
In the case of new applications or amendments to production and import licences, the IGJ weighs up per situation, in consultation with the BD, whether a physical inspection can be carried out on site, or whether an assessment can be performed in some other way.
The expectations regarding the above and other changes to guidelines due to the COVID-19 pandemic can be found on the EMA website.