Implementation date and batch-specific variations

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 Medicines 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

1. Section 6 (last paragraph) in the package leaflet for human medicinal products shall contain a reference to Felleskatalogen.no . See «Q&A» below for further information.
2. The last approved Package Leaflet shall be available on 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 Felleskatalogen.no in the package leaflet?

For human medicinal products, the hyperlink to the Felleskatalogen.no shall be inserted in Section 6 after the date of approval.

National procedure (NP)

The following sentence shall be inserted in the Norwegian package leaflet: «Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til 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 legemidlet er tilgjengelig på nettstedet til 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)).

Centralised procedure (CP)

For centrally authorised medicinal products, the reference to the Felleskatalogen.no shall be found in the printed version of the package leaflet, but it may be inserted in the Norwegian electronic leaflet (e-PL).

The wording for the medicinal products in centralised procedure shall be as follows:

«Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til Det europeiske legemiddelkontoret (the European Medicines Agency): http://www.ema.europa.eu , og på nettstedet til Felleskatalogen.no.»

When to implement the information about the Felleskatalogen.no in the package leaflet?

The reference to the Felleskatalogen.no shall be implemented with the first variation application concerning the Norwegian package leaflet, in all four procedures for approval (Centralised, MRP/DCP and national). Consequently, the reference implementation shall not be applied for with a separate variation application/notification 61(3).

How often 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 Felleskatalogen.no is included in the package leaflet, and the last approved package leaflet is uploaded in Felleskatalogen.no within 3 months after the date of approval, 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 URL to the 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:

• MRP and DCP (pdf)
• Centralised Procedure (CP) (pdf)