Recommended updates of the product information
Published:
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Updated:
Changes
- : Gathered inormation on the different types of recommendations on updates of the product information
- : Changed according to the Norwegian site.
In accordance with Article 16(3) of Regulation (EC) No 726/2004 and Article 23(3) of Directive 2001/83/EC, the MAH is responsible to keep its product information updated in line with current scientific knowledge and recommendations.
Recommendations from PRAC
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing all aspects of risk management of human medicine. The NOMA participates actively in this committee and follows up nationally on recommendations issued after assessment.
One of the tools used in pharmacovigilance is spontaneous reporting. Spontaneous reporting provides signals of adverse reactions; using epidemiological and statistical methods. These signals can be substantiated and tested.
PRAC recommendations on safety signals
A signal can be generated from various sources, such as spontaneous reporting, clinical trials, and scientific literature. Signal management in the EU is defined under Article 107h of Directive 2001/83/EC.
The texts should be used when preparing new product information, and the updates should be implemented by the MAHs submitting variation applications for the relevant medicinal products, in accordance with the The texts should be used when preparing new product information, and the updates should be implemented by marketing authorisation holders (MAHs) submitting variation applications for the relevant medicinal products, in accordance with the European Commission’s guidelines on the classification of variations (PDF)
(External link)
and the CMDh’s Article 5 recommendations(Ekstern lenke)(Ekstern lenke)European Commission's guidelines on the classification of variations(Ekstern lenke)(Ekstern lenke) and CMDh's Article 5 recommendations(Ekstern lenke)(Ekstern lenke).
The NOMA encourages MAHs to follow up on these recommendations and to use the Norwegian translations published both on the EMAs website and under(Ekster Norske oversettelser av PRAC etter utredning av signaler (Norwegian only).
PRAC recommendations on referral with CMDh consensus
Applications to implement changes to product information following joint recommendations shall be classified as C.I.1, and the update must be submitted in accordance with the European Commission’s guidelines on the classification of variations.
The NOMA continuously updates the list of PRAC recommendations that have been adopted by CMDh consensus (meaning the matter is not referred to the European Commission for a decision). We encourage MAHs to use the recommended texts.
Referral adopted by the European Commission
The Norwegian Medicines Agency implements CHMP arbitration updates nationally as the respective Commission Decisions are issued.
It is expected that a fully updated documentation is sent to our Agency in order to implement the CHMP arbitration decision:
- Annex I SmPC in Norwegian*
- Annex III a-b PIL and line listing in Norwegian**
- Annex IV (acceptable in English)
- Artwork (outer and inner) packaging sheets for the Norwegian market***
* Art 29, Art 30, Art 31
** Art 29, Art 30
*** Art 29, Art 30
The Product Information texts in Norwegian shall fully correspond to the Product Information Annexes enclosed to the Commission Decision, including the paragraphs that are to be completed nationally.The Norwegian Product Information should be sent in Word files tracked for the updates as result of the ended CHMP referral to arbitration to pi@noma.no.
For rules related to the national implementation process of a CHMP referral to arbitration (original product og generics) please see the ”Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products(External link)” (see page 68).
The Norwegian Medicines Agency hereby informs that the evaluation time for the review of the texts shall be additionally extended each time the texts do not comply with the requirements, as mentioned above. The Norwegian Medicines Agency encourages the generic product MAHs to apply for a type IB or Type II variation, according to the Variation Regulation, for updates of their products after an original/reference medicinal product has been updated by a CHMP referral Art 30 Dir. 2001/83/EC(External link) (see section 4).
It is suggested that Art 31 Dir 2001/83/EC updates of the original/reference medicinal product are followed by the generic products’ updates.
OTC packages
No subsequent update of the OTC packages after finalised Art 30 and 31 of Directive 2001/83/EC in CHMP referral to arbitration for the medicinal product. Any updates of the OTC packages for the medicinal product in question shall be proceeded with a variation application according to the Classification Guideline for the Variation Regulation 1234/2008/EC.
PSUR Single Assessment (PSUSA)
PSUSA is a safety report required by the European Medicines Agency (EMA) from marketing authorisation holders (MAHs) for all medicinal products for human use. It includes information on the medicinal product’s safety profile, including new safety concerns identified after marketing authorisation.
Periodic Safety Update Reports (PSURs) are pharmacovigilance reports intended to provide an evaluation of the benefit-risk balance of a medicinal product at defined time points following its marketing authorisation.
MAHs submit PSURs periodically after the medicinal product has been authorised. EMA and the national competent authorities carry out a single assessment of all medicinal products containing the same active substance or combination of active substances in order to determine whether there is a need to update the marketing authorisation (MRP/DCP/national).
The PSUR Single Assessment in the EU is defined under Article 107e of Directive 2001/83/EC. For further information regarding the procedure, please see EMA website.
If the PSUR Single Assessment procedure results in an update to the product information, this will be implemented within the PSUR Single Assessment procedure for medicinal products authorised through the centralised procedure. For medicinal products authorised at national level, including the MRP/DCP and national procedures, variation applications must be submitted.
Applications for the implementation of changes to the product information following a Commission Decision must be classified as C.I.3, and the update must be applied for in accordance with the European Commission’s guidelines on the classification of variations, which entered into force on the 4th August 2013.
Paediatric Regulation art. 45 og 46 worksharing
The MAH is requested to submit a variation application (Type C.I.3) in order to implement the proposed changes.
As follow-up to worksharing procedures pursuant to Articles 45 and 46 of the Paediatric Regulation (EC) No 1901/2006, the holder is requested to submit a variation application (Type C.I.3) for the implementation of the proposed changes. Any changes to the SmPC and package leaflet (PL) are set out in the published assessment reports (Articles 45 and 46).
Please also see the guidance available on the CMDh website regarding Paediatric Worksharing.