Transcript PAC-FUM-KAG-final

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
yes
no
Accaptance of PAC in national cases
AT
DE
BE
HU
CZ
LV
PL
DK
10
EE
13
PT
no information
SK
UK
no
FR
yes
IE
IS
7
NO
SE
MRP/DCP as an RMS
Acceptance of PAC in MRP/DCP as an RMS
yes
AT
BE
no
13
HU
no information
LV
no
DE
yes
DK
EE
PL
4
SK
CZ
13
FR
IE
IS
NO
PT
SE
UK
2.) Do you have a separate special procedure to
handle the submission of PAC/FUM?
CMDh
Separate procedure for PAC
DK
LV
Yes
No
EE
UK
FR
AT
3
BE
6
13
no information
HU
no
IS
CMDh
PL
PT
SE
SK
yes
CZ
DE
IE
8
NO
3.) Do you have a national legislative basis related
to the PAC/FUM? If yes, what does it contain?
no
BE
Natoinal law
CZ
EE
HU
yes
4
IE
DE
14
IS
no information
LV
yes
NO
PL
PT
SE
UK
no
12
DK
FR
SK
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
Legal conseqences
yes
BE
AT
EE
CZ
HU
IE
DE
8
13
IS
none or nothimg special
LV
yes, vary/suspend/withdraw
PL
9
PT
UK
no information
DK
FR
NO
SE
SK
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revoked, withdrawn or varied where the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: 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.)
CMDh
Update AR
DE
DK
UK
Yes
AT
No
CZ
EE
14
PL
PT
Yes (but it depends on the
PAC)
No
HU
LV
No information
IE
8
FR
IS
BE
3
CMDh
5
SE
SK
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.
Thank you for your attention!