handling post approval commitments & follow up measures in the eu environment
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
Handling Post Approval Commitments & Follow Up
Measures in the EU environment
Ágnes Gabriella Kelemen, MDHungary, 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
Accaptance of PAC in national cases
13
7
10
no information
no
yes
yes
AT
BE
CZ
DK
EE
FR
IE
IS
NO
SE
no
DE
HU
LV
PL
PT
SK
UK
no
HU
LV
PL
SK
yes
AT
BE
CZ
DE
DK
EE
FR
IE
IS
NO
PT
SE
UK
Acceptance of PAC in MRP/DCP as an RMS
13
4
13no information
no
yes
MRP/DCP as an RMS
2.) Do you have a separate special procedure to handle the submission of PAC/FUM?
Separate procedure for PAC
13
8
6
3
no information
no
yes
CMDh
CMDh
DK
LV
UK
No
EE
FR
HU
IS
PL
PT
SE
SK
Yes
AT
BE
CZ
DE
IE
NO
3.) Do you have a national legislative basis related to the PAC/FUM? If yes, what does it contain?
no
BE
CZ
EE
HU
IE
IS
LV
NO
PL
PT
SE
UK
yes
DE
DK
FR
SK
Natoinal law
4
14
12
no information
no
yes
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?
no
BE
EE
HU
IE
IS
LV
PL
PT
UK
yes
AT
CZ
DE
DK
FR
NO
SE
SK
Legal conseqences
13
9
8
no information
none or nothimg special
yes, vary/suspend/withdraw
DIRECTIVE 2001/83/EC Article 116 The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is
taken that the 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An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in Article 8 or Articles 10, 10a, 10b, 10c and 11 are incorrect or have not been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: noIn 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.)
Yes
AT
BE
IE
SE
SK
No
CZ
EE
FR
HU
IS
LV
PL
PT
CMDh
DE
DK
UK
Update AR
14
5
8
3 No information
Yes (but it depends on thePAC)
No
CMDh
Canada – special case4 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.
Thank you for your attention!