As of November 20, 2017, the National Institute for Pharmacy and Nutrition (Hungarian acronym: "OGYEI") has amended the notification of food supplements, baby formulas and special medical purpose nutrition supplements.
According to the OGYEI Director General, these changes were necessitated to shorten the length of notification proceedings and reduce the Institute's liability associated with their individual product risk assessment.
Changes in the Process
Pursuant to the new regulation, distributors shall receive their notification confirmation from OGYEI within 30 days of submission. When properly done, the confirmation shall inform the distributor that the notification conforms to the applicable regulations but shall not include any product assessment information.
To ensure effective market supervision and consumer protection, OGYEI shall continuously perform product risk assessment analyses but will separate them from the notification proceedings.
Complying with the new regime, the risk assessment activity of OGYEI shall primarily focus on those products that due to their composition or labelling carry a public health risk. OGYEI shall send the product risk assessment reports directly to the market supervision authority, currently the Deputy State Secretariat Responsible for the Chief Medical Officer's Duties at the Ministry of Human Capacities (Hungarian acronym: "EMMI OTFFH").
These changes do not affect the documents, data and forms required for filing at the time of the product notification with OGYEI.
The new regulations will eliminate the markings OGYEI used before for each notified product, such as
To maintain continuous provision of appropriate public information, OGYEI will publish the list of notified products and a separate list of those products that are subject to market supervision proceedings instituted by EMMI OTFFH.
Food for Special Medical Purpose
In accordance with Commission Delegated Regulation (EU) 2016/128 ("Commission Regulation"), special medical purpose supplements will be renamed to 'food for special medical purpose' as of February 22, 2019.
The revised name of the food product may trigger other changes in the special medical purpose food products and result in less advantageous sales tax or VAT brackets. The Regulation also establishes nutritional and compositional requirements that must be met for all special medical purposes food products.
From the effective date of the Commission Regulation food for special medical purposes products may not carry or reference health claims.
OGYEI recommends that manufacturers and distributors of these products follow the relevant regulatory changes and prepare to comply with their obligations concerning product notification, and the renaming and distribution of food supplements.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.