Are you familiar with the RIP acronym? How is it linked to Regulatory Affairs?

The Product Information is the scientific business card of a pharmaceutical product, promoting the quality, efficacy, and safety of pharmaceutical products.

Its translation into accurate and up to date information or promotional material is a key responsibility of a RIP, but it is only the visible part of many RIP duties to be conducted in close collaboration with notably Regulatory Affairs to ensure full compliance with regulations and laws.

RIP acronym stands for Responsible person for Information and Publicity. Each Marketing Authorization Holder (MAH) active in Belgium must appoint a RIP.

There are circumstances where RIP and Regulatory Affairs (RA) department should work closely together. Here are non-exhaustive examples of it:

  • In relation with Risk Management Plan (RMP) or Risk Mitigation Activities (RMA): The RIP must be aware of the mandatory activities and their specificities to be sure it is implemented when the MAH communicates externally about the product
  • As soon as the RIP is made aware of a demo pack/medical device intended to be used for promotional campaigns, the RIP must liaise with RA to ensure the notification of the medical device to the authorities or notified bodies has taken place prior to launch of the campaign. Also, the RIP will evaluate if the medical device falls into the category of items of negligible value or not and take the necessary actions accordingly.
  • When the MAH wants to distribute samples of a medicinal product, the RIP checks that at least one commercial pack is commercially available on the market
  • Whenever the Product Information, (i.e. SmPC, PIL, but also labelling) of a medicinal product not registered via the centralized procedure is updated, the RIP must check the accuracy of translations into the other Belgian languages and sign the certificate of translation
  • Samples labelling mock ups prepared by RA for promotional campaigns must be reviewed by RIP to ensure compliance with provisions of the Royal Decree of 1993 on samples.

Are you preparing a promotional campaign and want it quickly approved? Or do you want to know why a RIP is critical to your business?

Q-support can provide you with an experienced, pragmatical and efficient Responsible person for Information and Publicity for your company.

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