To the attention of interested persons
On Wednesday, 20 May 2015, representatives of several patient associations met for discussion in a panel organised by the National Agency for Medicines and Medical Devices (NAMMD). Issues considered were EU pharmacovigilance activity, monitoring and review of the safety profile of certain medicinal products or medicinal products classes.
Agency specialists explained the procedures and stages allowing maintenance of marketing authorisations (MAs), with amendment of Product Information (therapeutic indications, manner of administration, doses, addition of new contraindications or special warnings etc.,) or, in certain cases, resulting in MA suspension or even withdrawal. Examples discussed included codeine, diclofenac, ibuprofen, combined contraceptives, medicinal products for the treatment of osteoporosis, metoclopramide, sibutramine etc. Accurate information was required, considering the recent media information potentially misleading patients.
Participants were representatives of the Association of Patients with Liver Diseases in Romania (APAH-RO), of the Give Life Association, the Federation of Associations of Diabetic Patients in Romania, the Association of Patients with Autoimmune Diseases, the Association for Rare Diseases, the Baylor Marea Neagra Foundation, the Romanian Transplant Association, the National Association of Haemophiliacs in Romania and the “Pavel” Association.
Representatives of patient associations stated their openness for sharing the information provided on the topics discussed with their respective members. Moreover, certain participants also proposed introduction of educational programmes for patients, developed with NAMMD support; the proposal was accepted by NAMMD management.
NAMMD representatives in the meeting were Dr. Marius Tanasa, vice-president of the Agency, specialists of the Pharmacovigilance and Risk Management Service, as well as representatives of the Policies and Strategies Department.
Concluding the meeting, NAMMD representatives reasserted their purpose to organise periodic meetings with representatives of patient associations on other issues of interest.