Article 61(3) notification: labelling or leaflet change outside the SmPC
An Article 61(3) notification tells the authority about a change to labelling or the package leaflet that does not affect the SmPC, with 90 days to object.
Article 61(3) of Directive 2001/83/EC provides that any proposed change to the labelling or package leaflet that is not connected with the summary of product characteristics is submitted to the authorities competent for authorising the product. If they have not opposed the change within 90 days, the holder may put it into effect. The procedure sits outside Commission Regulation (EC) No 1234/2008, so it is not a variation and carries no variation category, although some Member States and EMA charge a fee for it. Typical examples are a new pack design, a change of layout or font, adding a pictogram allowed under Article 62, rewording the leaflet for readability without changing its content, or updating the local representative in the leaflet where that is handled this way.
For centrally authorised products the notification goes to EMA with the revised product information in the QRD format, and EMA checks it against the current Annexes. For products from mutual recognition or decentralised procedures the CMDh procedure applies: the holder submits to the reference member state and all concerned member states at the same time, and the RMS coordinates any objection. For purely national authorisations the national authority runs its own version. The test is always whether the SmPC is touched; the moment the change carries SmPC content, for instance a safety warning, it has to be filed as a variation instead.
What goes wrong: changes that look cosmetic turn out to alter content, such as a leaflet rewrite that drops a warning, and are rejected as misfiled; holders implement at Day 90 without checking that no objection arrived at one concerned member state; artwork is printed before the notification closes and must be scrapped; and teams forget the national Blue Box, which is a separate national matter and not part of the notification. Member States also differ on whether updated mock-ups are required and on how the 90 days are counted, so the national requirements have to be checked market by market. Keeping a register of what each authority accepted, and when, avoids repeating the same objection at the next pack change and shows an inspector that every printed version had a basis.
Timing
The authority has 90 days from receipt of a valid notification to oppose the change. Silence at the end of the 90 days means the holder may implement it. An objection stops the clock and the holder revises the proposal or files a variation instead. For MRP and DCP products the 90 days run in every concerned member state at once, so the implementation date is the day after the last authority's deadline passes, and some national authorities confirm acceptance in writing while others do not.
Used in
Before an Article 61(3) notification goes out, compare the new artwork with the approved text in Print Proofreader so the only changes are the intended ones.
Related terms
- Labelling: text on the outer and immediate packagingLabelling is the information Articles 54 and 55 of Directive 2001/83/EC require on a medicine's outer and immediate packaging, from name to batch number.
- Package leaflet: patient information leaflet in the packThe package leaflet is the patient-facing text in every medicine pack, required by Articles 58 and 59 of Directive 2001/83/EC and based on the SmPC.
- Mock-ups: full-colour drafts of packaging and leafletMock-ups are full-colour, actual-size drafts of the outer packaging, immediate packaging and leaflet that authorities review before a medicine is marketed.
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- Blue Box: national information on packaging in MRP and DCPThe Blue Box is the blue-bordered area on EU packaging and leaflets that carries national particulars such as price, reimbursement and legal status.
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