Regulation 3 Restrictions on saleF1
Northern Ireland
No person shall sell a medical food unless—
its formulation and composition comply with Article 3 of the Directive as read with the Annex thereto and its instructions for use are such that its use in accordance with those instructions would so comply;
the name under which it is sold complies with Article 4(1) of the Directive; and
it is labelled in accordance with Article 4(2) to (5) of the Directive.
No person who, in respect of medical food of a particular type—
is a designated notifier, that is to say a manufacturer or an importer covered by Article 5 of the Directive, but
has failed to comply with the requirement to notify the competent authority referred to in that Article,
shall sell a medical food of that type.
For the purposes of paragraph (2) the competent authority is the Food Standards Agency.