A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
The printed package leaflet of the medicinal product must state the name
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Medicinal product subject to medical prescription.
authorised and address of the
C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the MedicinalMarketing Authoris tion is in place and functioning before and whilst the medicinal product is on the market.
Risk Management Plan (RMP)
The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT