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Pharmacovigilance legislation – questions and answers

29 May 2012, Updated 11 April 2014

The Danish Health and Medicines Authority is receiving many questions about the new pharmacovigilance legislation. Below we provide answers to a selection of the questions we have received.

The European Medicines Agency (EMA) has also published questions and answers on the new pharmacovigilance legislation:


Are we to report non-serious adverse reactions to the Danish Health and Medicines Authority during the transition period?

During the transition period, all non-serious suspected adverse reactions occurring in Denmark must be reported to the Danish Health and Medicines Authority within 90 days.

The transition period starts in July 2012 and runs until the EudraVigilance database has been expanded with the required functionality. The EudraVigilance database needs to be expanded to handle the submission of increasing numbers of adverse reaction reports, and further functionality will be added as well.

Once the expansion of the EudraVigilance database is complete, marketing authorisation holders will only have to report adverse reactions to the EudraVigilance database.

It has not yet been specified when the expansion of EudraVigilance database is ready. The new rules on reporting of adverse reactions to EudraVigilance will come into effect six months after the database's new functionality has been implemented and announced by EMA.


Will the Danish Health and Medicines Authority request us to nominate a contact person for pharmacovigilance issues in Denmark?

Only in special cases and if considered required will the Danish Health and Medicines Authority request the nomination of a contact person for pharmacovigilance issues who must report to the qualified person responsible for pharmacovigilance (QPPV).


During the transition period, which adverse reaction reports must be reported to the Danish Health and Medicines Authority?

During the transition period from July 2012 and until EMA has ensured full functionality of the EudraVigilance database the individual Member States must receive the adverse reaction reports.

The reporting rules applicable to marketing authorisation holders during the transition period and the final reporting rules are given in the table below.

Marketing authorisation holders - Transition period

Marketing authorisation procedure

Origin

Adverse reaction type

Destination

Time frame

Centralised

MRP, decentralised or subject to referral

National

EU All serious

Member State where adverse reaction occurred

15 days
EU Non-serious

The Danish Health and Medicines Authority if the adverse reaction occurred in Denmark (during the transition period).

90 days

Non-EU

All serious EudraVigilance database 15 days

Marketing authorisation holders - Final arrangement

Marketing authorisation procedure

Origin

Adverse reaction type

Destination

Time frame

Centralised

MRP, decentralised or subject to referral

National

EU

All serious

EudraVigilance database

15 days

EU

Non-serious EudraVigilance database 90 days

Non-EU

All serious

EudraVigilance database

15 days


When will the new legislation apply?

The directive (Directive 2010/84/EC) is to be implemented into Danish law, coming into effect on 21 July 2012. The directive applies to medicinal products approved by the mutual recognition procedure, decentralised procedure and national procedures.

The regulation will apply from 2 July 2012 and generally covers centrally authorised products (Regulation (EU) No 1235/2010).


What about suspected serious adverse reactions occurring outside the EU (third countries) – must they be reported to the Danish Health and Medicines Authority during the transition period?

Suspected serious adverse reactions occurring outside the EU during the transition period are only to be sent to the EudraVigilance database during the transition period.


What about reporting of non-serious reports during the transition period from non-interventional studies initiated after July 2012 – must they be reported to the Danish health and Medicines Authority?

The Danish Health and Medicines Authority must receive non-serious adverse reactions from non-interventional studies within 90 days during the transition period.

Non-interventional studies should be distinguished between those with primary data collection directly from patients and healthcare professionals, and study designs which are based on secondary use of data such as studies based on medical chart reviews or electronic health care records, systematic reviews or meta-analyses.

Only reports of adverse reactions suspected to be related to the studied medicinal product by the primary source or the marketing authorisation holder should be reported to the Danish Health and Medicines Authority.

For non-interventional study designs which are based on secondary use of data, adverse reactions reporting is not required. These data should only be summarised in the final study report.

Serious adverse reactions from non-interventional studies must be reported within 15 days.


What about reporting of adverse drug reactions from non-interventional studies published in the scientific literature?

Adverse drug reactions from non-interventional studies published in the scientific literature should only be reported to the Danish Health and Medicines Authority if either the authors of the literature article or the marketing authorization holder (or both) asses a causal relationship between the drug and the adverse drug reaction. The assessment should be stated in the individual case safety report.

Adverse drug reactions from non-interventional studies shall always be reported to the Danish Health and Medicines Authority as “Report type” = “Report from study” and “Study type” = either “Other studies” or “Individual patient use”.


Will the Danish Health and Medicines Authority request reports of non-serious adverse reactions from ongoing non-interventional studies initiated before July 2012?

The Danish Health and Medicines Authority will not request reports of non-serious adverse reactions from ongoing non-interventional studies initiated before July 2012.

Serious adverse reactions from non-interventional studies must still be reported within 15 days.


Should PSURs be submitted for generic products in July 2012?

Submission dates provided in the Work Sharing/Synchronization lists are given as any date of the month, but should comply with the current legislation (½,1,3 years) until the new legislation comes into force.

If the marketing authorization holder has previously submitted PSURs by a date later than 21. July (or 2. July for centrally authorized products), the new legislation will have come into force by the submission date and no PSUR submission is therefore required for the generic product.

If the marketing authorization holder has previously submitted PSUR’s by a date before 21. July (or 2. July for centrally authorized products), PSURs in July should still be submitted according to the current legislation.

Example: A generic product (authorized under the legal basis of Article 10(1) of Directive 2001/83/EC, without specific conditions in the MA) containing an active substance for which the submission date according to the Work Sharing/Synchronization lists are due in July 2012.

The marketing authorization holder has previously submitted PSURs by the end of the month. Should a PSUR be submitted in July?

Since the company has previously submitted PSURs by the end of the month (after 21 July) no PSUR should be submitted for this generic product in July 2012.