In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
For the attention of applicants: the Center’s website has updated the publication “Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and grounds for amending the registration materials of medicinal products containing sildenafil”.
Primary information is available at the links:
