It is Mandatory Again for Medical Sales Representative to Obtain and Carry the OGYEI Issued Identification Card for the Promotion of Medicinal Products and Medical Aids

As of July 5, 2018, under the most recent amendment to Decree No. 3/2009 (II. 25) of the Minister of Health on the Detailed Rules Relating to the Promotion of Medicinal Products and Medical Devices for Human Use, the Registration of Persons Performing Promotion Activities and the Commercial Practices Related to Medicinal Products and Medical Devices Aimed at Consumers (hereinafter: “the Decree”), it is once again mandatory for medical sales representatives to obtain and carry the OGYEI issued medical sales representative identification card to engage in the promotion of medicinal products or medical aids.

If the marketing authorization holder, the manufacturer or the distributor of a medicinal product or a medical appliance or any other business organization commissioned by them carries out promotional activity, they are obliged to notify the National Institute for Pharmacy and Nutrition (OGYEI). The entity must send the sales representatives’ data specified in Section 12 of Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (the “Drug Economy Law”) within 8 days following the establishment of their legal relationship and register them with OGYEI for a specified period or indefinite period of time as stated in the registration petition.

Sales representative identification cards include the full name of the sales representative, his or her photo and registration number, the expiry date of the card (if any), and the name of the entity on whose behalf they carry out the promotional activity. The fee for the issuance of the sales representative identification card is HUF 12,900 per person. The administrative service fees related to the promotion of medicinal products, medicinal appliances and dietary supplements are detailed in a separate form and paid in a single sum, equaling to the fee to be paid on the basis of the number of all simultaneously registered sales representatives.

The content of this newsletter is for information purposes only and should not be treated as legal advice by KNP LAW Nagy Koppany Varga and Partners or any of their attorneys. For more information please contact us.