Pharmaceutical Newsletter 2018/1.

1. The National Institute of Pharmacy and Nutrition (hereinafter: ‘OGYÉI’) has performed several modifications regarding the scope of notification processes and databases.

1.1.  notification of supports provided in connection with professional events

Promoters of medical products shall electronically perform the notification by Section 14 (10) of Act XCVIII of 2006 (hereinafter: ‘Gyftv.’) to the OGYÉI 15 days prior to the commencement of the professional event or training course.

The notification by electronical letter is replaced by the interface established for such specific purpose by OGYÉI, available in Hungarian language herein: https://rendezveny.ogyei.gov.hu/

In order to perform the notification not only the documents defined by the Gyftv. shall be filed, but in addition the promoters of medical products shall register on the new interface, which they may apply following the approval of OGYÉI.

1.2. notification of food supplements, infant formulas and foods for special medical purposes

As of 20 November, 2017, OGYÉI modified the regulations on confirmation of notification on food supplements, infant formulas and foods for special medical purposes. The most significant innovation of the present decision is that the confirmation regarding the notification shall be received in 30 days. In case of priorly notified products, OGYÉI will send a confirmation which complies with the new procedure.

The relevant lists are available in Hungarian language on the website of OGYÉI by the links below, in which lists the notified products are listed in a table, while the products influenced by market supervisory measures shall be designated in a separate list.

https://www.ogyei.gov.hu/etrend_kiegeszitok/

https://www.ogyei.gov.hu/Specifikus_csoportoknak_szant_elemiszerek/

1.3.  database on clinical trials

As of 15 November, 2017, OGYÉI published its brand new database, which is intended to assist the doctors and patients interested in clinical trials as due to the database the list on data of the clinical trials licensed by OGYÉI and performed in Hungarian premises is available for the public. Such information may have been searched in the EU Clinical Trials Register, which database includes the data of clinical trials performed in the territory of the EU.

Due to the new database above, it is possible to search for information regarding clinical trials licensed or commenced in Hungary. However, the list is monthly updated therefore the licenses priorly issued are to be published continually.

https://www.ogyei.gov.hu/listak

https://www.clinicaltrialsregister.eu

2. Guide regarding the application of nutrition and health claims released by OGYÉI

The OGYÉI has published the guidance made by its Department of Food Chemistry on its website, which contains information on the application of nutrition and health claims.

The OGYÉI has published the guidance made by its Department of Food Chemistry on its website, which contains information on the application of nutrition and health claims.

We would like to emphasize that the guide may not be considered as interpretation of the relevant legal regulations and it may not contain regulatory provisions. However, it may be considered as a recommendation to our Clients with regard to the fact that the authority may investigate the compliance therewith in a potential procedure.

The publication provides answers to questions, e.g. what shall be considered as claim, what nutrition and health claims mean. OGYÉI not only explains the answers to the questions above, but it provides classification by the explanations of the legal regulations and it demonstrates the legality of the given claims with examples.

The guide is available in Hungarian language on the following link:

https://www.ogyei.gov.hu/megjelent_utmutato_a_tapanyag_osszetetelre_es_egeszsegre_vonatkozo_allitasok_hasznalatahoz/

Should you have any questions or queries regarding the performance of the notifications or the indication of information included in the lists and databases or the information published in the guide above, please do not hesitate to contact Germus & Partners Attorneys-At-Law, which has extensive expertise, theoretical and practical experience in the field of pharmaceutical law and is able to provide you practical and client-oriented solutions.

The content of the present document is only for your information and it shall not be considered as legal advice of Germus & Partners Attorneys-At-Law or any attorneys or trainee lawyers thereof.

You may contact us anytime via office@germus.hu, we are your kind disposal.