Before starting to supply food products for infants and young children, food products for special medical purposes (SMPMP) and total diet replacements for weight control, it is necessary to notify the responsible authorities in each target market about the product. Notification is a complex process involving the submission of a notification report, all necessary documents, correct labelling in the national language, and other relevant information about the product to the competent authority. This is followed by approval for the legal supply of the product.
Based on our many years of experience and successful practice in the notification of food products for special medical purposes in the EU and other countries, we provide the following services:
- We advise on SMPMP notification issues.
- We prepare and submit notification reports and accompanying documents to the competent authorities.
- We maintain communication with the responsible authorities throughout the notification process.
- We perform other necessary actions for successful SMPMP notification in the Baltic countries, the EU, and other countries.
When notifying food products for special medical purposes, the notification report and all other documents are submitted in accordance with the procedure established by the responsible local authorities. If there is a need to notify products in this category in several countries, we carry out multilateral projects in cooperation with long-standing partners who help to ensure compliance with the standards and best practices of each target market.
SMPMP notification: what should you pay attention to?
When considering importing a product from third countries into an EU country or countries, it is recommended to contact the manufacturer and make sure that they can provide all the necessary information: the master text in English, the original packaging layout, product specifications (including ingredient quantities, extract quantities, conditions of use), etc.
When importing SMPMP from non-EU countries, it is first necessary to assess their composition in principle and ensure that there are no critical obstacles that would prevent the product from being supplied in EU countries. This requires an assessment of the national requirements of the countries to which the products are to be supplied.
- Before notifying SMPMP, the entity must have a food business operator approval certificate.
- If the SMPMP has already been notified in another EU country, this does not necessarily mean that it will be successful in a new market.
- When seeking to notify a product in several countries, it is particularly useful to plan the procedure in accordance with national requirements, especially if the product to be supplied to the market is not manufactured in the EU.
- There is a fee for notification, the amount and frequency of which varies between EU countries.
Countries where we provide SMPMP notification services
The notification of special medical devices is closely linked to national requirements. We liaise with the authorities responsible for this process and ensure the legal compliance of products in the Baltic countries, Poland, and other countries (subject to separate agreement).
Why is it worth turning to experts?
When notifying SMPM products, it is important to have a good understanding of not only the regulatory procedures and requirements. In order to successfully introduce a product to a new market, it is particularly useful to know what requirements and expectations retail chains and shopping centre chains in a particular country have for products and their suppliers.
Our team and partners in other EU countries are experienced regulatory experts who speak the local language and have a thorough understanding of national legislation and market practices. Considering the specifics of your products, we will help you ensure compliance with EU and national regulations, smoothly notify your product, and ensure that it successfully reaches the market.
Let us know your needs, and we’ll help you find the right solution!
