Industry plays up mutual recognition potential

The European Federation of Associations of Health Product Manufacturers (EHPM) said the regulation, which was adopted in July this year, was expected to operate as a user ‘friendly means’ of helping manufacturers to launch in new EU markets.

Contact point​

Serving primarily to outline existing regulations on launching products nationally, the EU legislation, designed to come into affect next May, also calls on member states to establish​Product Contact Points that can inform manufacturers of specific challenges of entering a country.

Companies, as a result of the regulation, are expected to be better aware of the procedures available when facing ‘technical’ rules that may restrict or force the reformulation of a product to enter certain markets.

Legal framework​

According to a spokesperson for the association, supplements and health products have previously been adversely affected by a lack of legal framework for entering member states.

“Unless there is a safety issue, most products legalised in one European market, are allowed for sale everywhere,”​ the spokesperson stated. “However, there have been problems for health products as the laws are not all harmonised, which has lead to some countries refusing entry on certain products.”​

Peter van Doorn, chairman of EHPM, said that there was a particular lack of knowledge across the industry and at authority levels about mutual recognition, a principle concerned with the free movement of goods among EU treaties.

“Within the various national markets the industry is largely under the impression that national rules prevail, and how to apply the principle of mutual recognition is not always clear,”​ he stated.

Clarifying rules​

While the Mutual Recognition Regulation offers little new for manufacturers in terms of principals, the EHPM says that it primarily clarifies national rules on market entry for industry players, health authorities and other officials.

The association spokesperson said that one new focus under the change was the Contact Point system. This has been set up as a mean of providing national rules on how similar products have been dealt with in a legal framework, with member state support seen as vital to the scheme.

“The contact system has to be set up by individual member states to provide accurate information to officials and industries alike,” ​said the spokesperson.

Industry workshop​

Following on from the legislation being adopted in the EU, a workshop involving health officials and industry members like EMPH and The European Responsible Nutrition Alliance (ERNA) took place earlier this month regarding regulatory concerns.

Mutual recognition was one of four areas of concern for attendees, with particular focus on the practical implications for industry of adopting the regulations.

Speaking at the event, ERNA chairperson Gert Krabichler said the new legislation was a major step forward for the industry, though implementation of these rules remains a key issue.

“How it will work in practice remains to be seen, but the regulation in theory is positive, and we hope that it will be effective in helping to break down barriers to trade within the EU,”​ Krabichler stated at the workshop.