Implementation date and batch-specific variations
Published:
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Updated:
Changes
- : Changed information regarding implementation of www.felleskatalogen.no for medicinal products in CP
Batches of medicinal products that are QP released 6 months or later after the approval date must have updated packaging and package leaflet. Delayed implementations in the packaging shall be applied for as batch-specific variations.
Page contents
Implementation deadline for packaging
Batches of medicinal products that are QP released 6 months or later after the approval date must have updated packaging.
Delayed implementations in the packaging, later than 6 months, shall be applied for as batch-specific variations.
Implementation deadline for package leaflet
All QP released batches for a medicinal product shall have updated package leaflet implemented at least 6 months after the date of approval. Nevertheless, the Norwegian Medical Products Agency may accept a 12 months implementation deadline from the approval date, if the conditions below are fulfilled.
Delayed implementations in the package leaflet, later than 6 months, which do not fulfil the conditions below, shall be applied for as batch-specific variations
Conditions for 12-month implementation deadline
- Section 6 (last paragraph) in the package leaflet for human medicinal products shall contain a reference to www.felleskatalogen.no . See «Q&A» below for further information.
- The last approved Package Leaflet shall be available on www.felleskatalogen.no web site within 3 months from the approval date.
NoMA may determine a shorter implementation deadline of the updates in the package leaflet. If the updates include any safety issues for the medicinal product, NoMA may demand immediate implementation with the first produced batch or consequent withdrawal.
Questions and answers (Q&A)
Where and how to include information about www.felleskatalogen.no in the package leaflet?
For human medicinal products, the hyperlink to the www.felleskatalogen.no shall be inserted in Section 6 after the date of approval.
National procedure
The following sentence shall be inserted in the Norwegian package leaflet: «Detaljert informasjon om dette legemiddelet er tilgjengelig på nettstedet til www.felleskatalogen.no»
MRP/DCP
The following sentence shall be inserted in the Norwegian package leaflet, in the national phase of the procedure: «Detaljert informasjon om dette legemiddelet er tilgjengelig på nettstedet til www.felleskatalogen.no»
The following sentence shall be inserted in the English package leaflet, at the first opportunity: «Detailed information on this medicine is available on the website of (name of MA Agency (hyperlink)).
CP
For centrally authorised medicinal products, the reference to the www.felleskatalogen.no shall only be found in the printed version of the package leaflet.
The following sentence shall be inserted in the electronic package leaflet: Detaljert informasjon om dette legemiddelet er tilgjengelig på nettstedet til Det europeiske legemiddelkontoret (the European Medicines Agency): http://www.ema.europa.eu.
The following sentence shall be inserted in the printed package leaflet: Detaljert informasjon om dette legemiddelet er tilgjengelig på nettstedet til Det europeiske legemiddelkontoret (the European Medicines Agency): http://www.ema.europa.eu, og på nettstedet til www.felleskatalogen.no.
When to implement the information about www.felleskatalogen.no in the package leaflet?
The reference to the www.felleskatalogen.no shall be implemented with the first variation application concerning the Norwegian package leaflet for approval (MRP/DCP and national procedure). Consequently, the reference implementation shall not be applied for with a separate variation application/notification 61(3).
How soon should updates in the package leaflet be implemented?
The implementation of the package leaflet updates shall be done as soon as possible and within 6 months from the approval date. However, if the hyperlink www.felleskatalogen.no is included in the package leaflet, and the last approved package leaflet is uploaded in www.felleskatalogen.no within 3 months after the date of approval, the NoMA shall accept an implementation deadline for 12 months.
When to apply for a batch-specific variation?
If the package leaflet fulfils the conditions for the 12 months implementation deadline, all delays beyond 12 months shall be applied for as batch-specific variations.
In those cases where the package leaflet does not fulfil the conditions for the 12 months implementation deadline, the delays beyond 6 months shall be applied for as batch-specific variations.
Is it acceptable to include codes with the URL to www.felleskatalogen.no in the package leaflet?
Codes with URL are acceptable. They have to be according to the guideline on «Mobile scanning and other technologies to be included in packaging and PL», and should refer directly to the relevant electronic leaflet (e-PL) on www.felleskatalogen.no for the medicinal product
Links to the guideline for mobile scanning and other technologies: