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Handling Post Approval Commitments & Follow Up Measures in the EU environment. Ágnes Gabriella Kelemen, MD Hungary, National Institute of Pharmacy. 1.) In marketing authorisation procedures ( as an RMS ) do you accept post-approval commitments (PAC) or follow-up measures (FUM)?. National.
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Handling Post Approval Commitments &Follow Up Measures in the EU environment Ágnes Gabriella Kelemen, MD Hungary, National Institute of Pharmacy
1.) In marketing authorisation procedures (as an RMS) do you accept post-approval commitments (PAC) or follow-up measures (FUM)? National
2.) Do you have a separate special procedure to handle the submission of PAC/FUM?
3.) Do you have a national legislative basis related to the PAC/FUM? If yes, what does it contain?
4.) What are the legal consequences in your national law if the applicant does not apply the commitment till the last deadline given by the RMS?
DIRECTIVE 2001/83/EC Article 116 The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken thatthe product is harmful under normal conditions of use, or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive under the normal conditions of use, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product.
An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in Article 8 or Articles 10, 10a, 10b, 10c and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out.
5.) Have you had any court cases related to PAC/FUM? If yes, what was the judgement/result of the case? In EEA: no In Canada: yes
6.) Do you update the AR with the assessment of the PAC/FUM? If yes, what is your method to that?(E.g. update the day210 FAR or update the PAR of the product, upload to the CTS etc.)
Canada – special case 4 no Legal consequences: They are limited. If a market authorization holder fails to adhere to a commitment the regulator can formally request evidence to establish the safety and/or effectiveness of the drug. If the MA fails to do this it will be compelled to stop selling the drug. It can also request Issue related summary reports under the new Pharmaco-vigilance Regulations that were enacted in March, 2010.
Centralized procedures The issue was raised recently for the centralized procedure through the different Committes or Working party’s. Our Belgian reflexion for the future is to stipulate the PAC as a condition to the national MA , to make it more legally binding. Today it is not the case.
