One of the key features of this newsletter is that it doesn’t assign anything that is just busywork. The Information is designed to capture the essential points, with an emphasis on those that directly relate to the individuals of the pharmaceutical Industry and helpful in sharpening the knowledge with current updates.
Very frequently do the Pharmacovigilance professionals come across terms such as RMS, MRP/DCP, CAP, CMS, etc., while interacting with the colleagues from the regulatory department. All these concepts are good to know, and are definitely relevant, as Pharmacovigilance requirements may vary across each of these terms. Besides, this is applicable to both human and veterinary medicinal products.
There is a single authorization for all of the member states in EU/EEA. MA number is common across all the member states.
This pertains to country-specific authorization where the MAH can commercialize the product only in one member state. A National Marketing Authorization is initially valid for five years from the date of first authorization. At the end of the five year period, it will be subject to renewal, which is a mechanism for reviewing the product to ensure the benefit/risk balance remains favourable. This review takes into consideration any further information obtained about the product from the experience gained of its use since it was first authorized, e.g. pharmacovigilance data. This is to ensure that the product’s MA is still appropriate. Following this review, the MA will be valid indefinitely, or the MAH will be asked to submit another renewal in a further five years’ time.
A product needs to be already authorized in at least one Member State on a national basis in order for MRP to be used. However, DCP may be used if the product is not already authorized in any Member State. This is mainly when the MAH does not want to use the centralized procedure, or the product is not eligible for the centralized procedure.
This is a free online resource from HMA, for finding information on the MRP/DCP in EU/EEA.
During the transition period (Feb-Dec 2020), the UK will not be able to act as RMS in MRP/DCP, but the UK can participate in MRP/DCP as CMS.
It is important to know this, as certain products may be supplied through this route. Compassionate use is a treatment option that allows the use of unauthorized medicine.
Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorized therapies and who cannot enter clinical trials. In the European Union, these programmes are only put in place if the medicine is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses, which cannot be treated satisfactorily with any currently authorized medicine.