End of January 2023, the Luxembourg authorities updated their document ‘Procedure for marketing authorisation applications in Luxembourg’: the version 3 was published on their website on January 20^th 2023 (a new tab was created in the excel file with information regarding the Product information). Source: Procédures au Luxembourg - Portail Santé - Luxembourg (public.lu).

MAHs have now to indicate the MA number(s) and/or the paragraph on the reporting of adverse reactions on the product information (SmPC, labelling and PIL, respectively) of medicinal products distributed from Belgium/France/Germany and intended for Luxembourg market.

It is a new requirement that the LU authorisation numbers need to be included in the product information.

Apparently, the Belgian FAMHP and the Luxembourgian DPM accept that the change of the product information can be carried out via an editorial change, at the time of a next submitted variation with impact on the product information.

However, the following conditions must be met:

- The change must be clearly indicated in the application form of the variation (scope and present and proposed) and in the cover letter.

- The implementation period is one year from January 21^st, 2023; this change can also be submitted separately as a variation of type IA C.I.Z..

After the one-year implementation period, these changes will be considered as IA C.I.Z. variations.

The exact template to use for the SmPC, labelling, and PIL can be found in tab 2 of the Excel sheet.

M.P.C.A. International BV can estimate the work that needs to be done to bring your marketing authorisations up to date.

We can brainstorm together and develop a retro planning communicating well with your Supply Chain to avoid the cost of destroying leaflets.

Please do not hesitate to contact us for any further information or assistance.

Don’t forget the sample management communication to the FAMHP in Belgium before March 1^st, 2023, for all samples delivered within the last calendar year 2022.

The delivery of free medicinal product samples by pharmaceutical companies, which is also a form of advertising, is regulated.

The marketing authorization holder can deliver samples, exceptionally, only to persons authorized to prescribe medicinal products and on their personal demand.

The maximum number of samples that can be awarded is limited to 8 per medicinal product, per calendar year and per person authorized to prescribe medicinal products.

The marketing authorization holder must have an adequate system for controlling the distribution of samples, under the responsibility of the responsible person for information and publicity (RIP).

This is described in the Belgian Royal Decree of 11 January 1993 establishing the conditions under which the delivery of medicinal products for human use as samples can be performed, and Circularly Letter n° 503.

For all practical information concerning medicinal samples please contact M.P.C.A. International BV.

We hold extensive experience in building a long-term high-quality, honest and flexible relationship with our clients, the marketing authorisation holders, to provide ongoing and continuing life cycle management for their medicinal drugs on the market.

A medicinal drug product is available to patients as from the first day of market access and can remain on the market for decades. From birth date to first market approval through product innovations such as new indications, formulations, line extensions, etc… each and every milestone in that lifecycle will be shaped and challenged by regulatory requirements.

A dedicated and pro-active regulatory affairs department is crucial during the lifecycle of a medicinal drug and should be included in the marketing authorisation holders’ lifecycle planning strategy.

In other words, regulators must act as a checkpoint at every critical milestone on the product journey. When companies build regulatory strategy into the product’s lifecycle plan, they can optimise value, reduce risk, control costs and ensure compliance.

Such long-term planning is common among the largest pharmaceutical companies where dedicated teams are on hand daily, but small and medium sized companies may lack the experience, expertise or resources to develop a comprehensive regulatory affairs strategy that can evolve with the product. This unplanned approach can create unexpected delays and potentially derail the long-term revenue potential of the product.

Such losses can be avoided when companies think through the product lifecycle during development to identify the regulatory expectations at every key milestone. This can help them proactively capture relevant safety and efficacy data to meet future global and local requirements.

When companies build regulatory strategy into the product's lifecycle plan, they can optimise value, reduce risk, control costs and ensure compliance.

Remember: good quality is mandatory, poor quality or lack thereof only leads to problems in the short- or long-term.