Mutual Recognition Agreement Process

Malta – Capacity excludes sterile or sanitized medicines and biologics; and non-sterile and highly effective medicines. Trade agreements are trade agreements designed to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety. There are also processes for addressing delinquent eCABs or defective behaviours. As soon as a problem has been identified with a CAB detected by an unknown person, IC informs the CAB and its designation authority of the problem. If the problem is not resolved, IC can ask the incanting authority to remove the CAB name and IC can also remove the recognition of that CAB. If the designated authority does not respond, IC may withdraw from the implementation of the MRA with six months` written notice. The Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from anti-drug inspections carried out within the other country`s borders. Under the Drug Safety and Safety Act passed in 2012, the FDA has the authority to enter into agreements on the recognition of drug inspections by foreign regulators when the FDA has found that these authorities are able to conduct inspections in accordance with U.S. requirements. The FDA and the EU have been cooperating since May 2014 to assess how they control drug manufacturers and assess the risk and benefits of mutual recognition of inspections. The first MRA Canada signed solely for telecommunications was with Korea. It was signed in Korea in January 1997, during a trade mission led by the Prime Minister. This MRA activity has been fuelled by complaints from the Canadian industry about the lack of transparency in access to the Korean market and allegations of copying and design fraud under the pretext of requiring highly detailed product design materials.

One of the key advantages of MRA is that it makes the entire market access process very transparent, which is an essential part of Canadian competitiveness in the international marketplace. The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products. These agreements contain a sectoral annex on mutual recognition of good manufacturing practice inspections (GMPs) and certification of batches of medicines for human and veterinary use. During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. An AEO status is required for the issuance of THE status of EOPA, in accordance with the relevant regulations. In addition, if the EOPA applicant holds an AEOS authorization, the application process is simplified.