Notification of dietary supplements to the Greek National Organization of Medicines
Our firm has experience in notification of dietary supplements to the Greek National Organization of Medicines (GNOM). More specifically, we undertake:
- preparation of the relevant notification dossier by collecting the documents
- translation of the documents in Greek or English
- online registration of the notifier to the GNOM website (collection of documents by company type and filing thereof)
- filing of the notification dossier to the GNOM
- monitoring of the process in the GNOM following the filing the dossier
- creation of a label in line with the Greek legislation for affixing on the packaging of the supplement
- stamping of the invoices to the GNOM to allow the import of supplements from non-EU countries
- customs clearance
- supervision of the advertising campaign of your company for the promotion of the supplements.
In other words, by assigning your case to our office you avoid a several month struggle of a complex process, which however, due to our long-term experience in this field, we are able to successfully accomplish much sooner.
The notification process of a dietary supplement to the GNOM, because of its complexity, the multitude of documents that must be completed and collected and the thorough legality check which a dietary supplement must undergo in order to determine if it complies with the Greek legislation, unfortunately prevents several importing companies, who are also responsible for the distribution of the supplements on the market, from notifying their products legally to the GNOM. As a result, many of the dietary supplements on the pharmacy shelves, perhaps most of them, do not indicate their GNOM notification number on their packaging, due to the fact that the importing company declined to notify them, for the reasons above.
The perception still prevails among the importers and the public that, if a dietary supplement has been notified in a country - member of the EU, no notification to the GNOM is required. Of course, this perception is incorrect.
We examine the active substances and the excipients of the dietary supplement, to determine if they comply with the Greek and European legislation, i.e. that if they are allowed to be contained in the composition of the supplement. If there’s any doubt for any active substance or excipient we submit a relevant inquiry to the GNOM, which gives oral replies. As it is the case of course with public services, the inquiry may be submitted in writing; however a longer time (possibly several months) is required to receive a reply, during which of course the notification process will be revoked.
Once we have ascertained that the contained active substances and excipients of the dietary supplement are in accordance with Greek legislation, we proceed to gather the necessary documents to complete the dossier. Indicatively, the trade name, the trade mark and the sales description of the product, the contact details of the importer – person responsible for its circulation and of the manufacturer, the qualitative and quantitative composition of the dietary supplement are all required to be notified. Furthermore, the separation and labelling of the ingredients is done according to their ranking by the Greek legislation. Suitability data on their nutritional purpose may need to be produced for some ingredients, along with scientific literature, as well as the specifications of the raw materials. Moreover, we submit an official dietary supplement analysis certificate from the producer, as well as the control methods of the ingredients. The above documents are collected following a consultation with the producing company.
We compile the official label of the product, in accordance with the Greek legislation, which we co-submit to the GNOM.
We receive the required fee of six hundred euros (€ 600) + 2.4% stamp with a deposit into the GNOM account in the Bank of Greece, which is necessary for the dossier to be examined by the competent committee. The fee shall be submitted independent of whether the circulation of the supplement to the market is revoked, after a negative decision of the committee.
We conclude the dossier consisting of the above relevant documents, the application and the fee. Subsequently we file the contents of the dossier electronically to the GNOM and receive a filing number.
Since the notification of the dietary supplements to the GNOM is now done electronically through its website, it is necessary for us to have the user name and password of the notifier in order to log-on to the system. These details are provided to us by the person submitting the notification dossier. If that person doesn’t have them, we instruct him to collect all the documents required by the GNOM to grant access to the system, which are different for each type of company. More specifically, different legal documents are required for issuing a user name and a password by the GNOM, depending on the legal form of the notifier (sole proprietorship - natural person, general partnership, limited liability company, etc.). We can also undertake the entire registration process of the person concerned in the GNOM electronic services portal, if assigned to us.
We collect all the necessary documents and give them to the GNOM, in order for the purchase invoices of the dietary supplements to be stamped and enable their importation into Greece.
We handle the entire process of customs clearance, in cooperation with an experienced customs agent.
The advertising of dietary supplements must follow specific legal rules to be lawful and ensure that there’s no risk of penalties and fines imposed to the person responsible for their distribution. It is common for companies to include health claims on the packaging and the brochures of the dietary supplements, which are not consistent with European legislation. The review of the legality of the advertising campaign of the supplements is undertaken by our firm.
Our experience in the food supplements importing sector is the guarantee for the importing company for the quality of our services provided and relieves the conscientious businessman from stress and time. Simultaneously it adds goodwill to food supplements, which are now provided and distributed with a GNOM notification number, while at the same time facilitating and increasing their sales. For all these reasons, we draw your attention: Do not risk the reputation of your business - Honour us with your confidence.
We invite you to fill in the special form by clicking here to receive free of charge a non-binding estimate of the cost of the notification of the food supplement to the Greek National Organization of Medicines (G.N.O.M.), which includes our fees, third-party fees and other minor expenses. We will also send you our customized fee for the evaluation of the formula (ingredients) of the dietary supplement according to the E.U. and Greek legislation and the requirements of the GNOM, which is the most important step prior to the notification of the product.