Pharmacovigilance legislation – questions and answers

The Danish Medicines Agency receives many questions about the new pharmacovigilance legislation. Below we provide answers to some of the questions we have received.

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

Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

Do we have to report non-serious adverse reactions to the Danish Medicines Agency during the transition period?

All non-serious suspected adverse reactions occurring in Denmark must be reported to the Danish Medicines Agency within 90 days during the transition period.

The transition period starts in July 2012 and runs until the EudraVigilance database is fully developed. The EudraVigilance database needs to be expanded to handle the increasing number of adverse reaction reports, and further functionality will be added as well.

Once the EudraVigilance database is fully developed, marketing authorisation holders will only have to report adverse reactions to the EudraVigilance database.

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

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

Generally, the Danish Medicines Agency will not request the nomination of a contact person for pharmacovigilance issues in Denmark who must report to the qualified person responsible for pharmacovigilance (QPPV), unless it is considered necessary.

Which adverse reaction reports must be submitted to the Danish Medicines Agency during the transition period?

During the transition period from July 2012 and until the 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 holders – Final arrangement

When will the new legislation come into effect?

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, the decentralised procedure and national procedures.

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

Should we submit suspected serious adverse reactions occurring outside the EU (third countries) to the Danish Medicines Agency during the transition period?

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

Should we submit non-serious adverse reactions from non-interventional studies initiated after July 2012 to the Danish Medicines Agency during the transition period?

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

Note that a distinction is made between primary data collection directly from patients and healthcare professionals, and secondary data collection based on patient records, systematic reviews, meta-analyses etc.

Only adverse reactions from primary data collection where a causal relationship is suspected between the medicine and the adverse reaction, assessed by either the patient or healthcare professionals or the marketing authorisation holder, should be reported to the Danish Medicines Agency.

Secondary data collection of adverse reactions from non-interventional studies should not be submitted to the Danish Medicines Agency on an ongoing basis. These data should only be summarised in the final study report.

Serious adverse reactions from non-interventional studies must be reported to the Danish Medicines Agency within 15 days.

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

Adverse reactions from non-interventional studies published in the scientific literature should only be reported to the Danish Medicines Agency if either the authors of the literature article or the marketing authorisation holder (or both) assess that there is a causal relationship between the medicine and the adverse reaction. The assessment should appear from the adverse reaction report.

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

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

During the transition period, the Danish Medicines Agency 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 to the Danish Medicines Agency within 15 days.

Should PSURs be submitted for generic products in July 2012?

The submission dates provided in the Work Sharing/Synchronisation 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 company has previously submitted PSURs on a date later than 21 July (or 2 July for centrally authorised 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 company has previously submitted PSURs before 21 July (or 2 July for centrally authorised products), PSURs should be submitted according to the current legislation on PSURs in July.

Example: For a generic product (authorised under the legal basis of Article 10(1) of Directive 2001/83/EC, without specific conditions in the marketing authorisation) containing an active substance, the submission date according to the Work Sharing/Synchronisation lists is in July 2012.

The company has previously submitted PSURs by the end of the month. Should a PSUR be submitted in July for this generic product?

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

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Reporting of adverse reactions seen in clinical trials exclusively related to non-investigational medicinal products

Adverse reactions occurring in a clinical trial that is exclusively related to non-investigational medicinal products and where there is no suspected interaction with the investigational medicinal product must be reported as spontaneous reports.

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When should SUSARs from other EU countries be reported to the Danish Medicines Agency?

All SUSARs from other EU countries should be reported to the Danish Medicines Agency as long as the study with the same EudraCT number is ongoing in Denmark. If SUSARs occur in other EU countries, before the study is initiated in Denmark, it is the responsibility of the sponsor to evaluate whether the events have an impact on the overall safety of the trial subjects and whether the Danish Medicines Agency should therefore be informed.