The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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Change 1
3 Amendments to regulation 1
In regulation 1 (citation, commencement and interpretation), in paragraph (2), insert the following definitions at the appropriate places— “calendar quarter” means a period of three months beginning on— 1st January; 1st April; 1st July; or 1st October; ; “calendar year” means a period of 12 months beginning on 1st January; ; “combination medicine” is to be construed in accordance with regulation 3B(8); “licensing authority” has the meaning given to it in regulation 3(5H); ; “medicines information standard” means the inter-operability standard for the transfer of medicines information that is published by NHS BSA in the document known as the dictionary of medicines and devices; ; “newer presentation” is to be construed in accordance with regulation 3B; ; “older presentation” is to be construed in accordance with regulation 3B(4) and (5); ; “originator” means, in relation to an active ingredient, or in the case of a combination medicine the combination of active ingredients, of a relevant medicine for a presentation— the person who— received the first marketing authorisation for the virtual therapeutic moiety of that active ingredient or combination of active ingredients, or is not the same as the person specified in paragraph (i) but who holds a valid supplementary protection certificate for the active ingredient or combination of active ingredients; or a person who acquires the ownership of the presentation from a person specified in sub-paragraph (a); ; “originator licensee” means a person, other than an originator, who is marketing a presentation and, during the period the presentation was a newer presentation, was— doing so under a licence from the originator permitting marketing of the relevant medicine; or in the same group as the originator for the relevant medicine; ; “vaccine originator” means, in relation to an active ingredient or a combination of active ingredients of a relevant medicine for a presentation that is a vaccine— the person who— received the first marketing authorisation of any presentation for the applicable virtual therapeutic moiety, is not the same person specified in paragraph (i) but who holds a valid supplementary protection certificate for the active ingredient or combination of active ingredients, or if different from the persons specified in paragraph (i) or (ii), was the first person to place the relevant medicine on the market for health service use and, at the time, the licensing authority designated the presentation to include a new active substance; or a person who acquires the ownership of the presentation from a person specified in sub-paragraph (a); ; “vaccine originator licensee” means a person, other than a vaccine originator, who is marketing a vaccine and was, during the period the presentation is a newer presentation— doing so under a licence from the vaccine originator permitting the marketing of the relevant medicine; or in the same group as the vaccine originator for the relevant medicine; ; “virtual therapeutic moiety” means the abstract representation of an active ingredient or active ingredients of a relevant medicine formulated in the medicines information standard as— a medicinal product; or in the case of a vaccine, an indication or indications; .
3 Amendments to regulation 1
In regulation 1 (citation, commencement and interpretation), in paragraph (2), insert the following definitions at the appropriate places— “calendar quarter” means a period of three months beginning on— 1st January; 1st April; 1st July; or 1st October; ; “calendar year” means a period of 12 months beginning on 1st January; ; “combination medicine” is to be construed in accordance with regulation 3B(8); “licensing authority” has the meaning given to it in regulation 3(5H); ; “medicines information standard” means the inter-operability standard for the transfer of medicines information that is published by NHS BSA in the document known as the dictionary of medicines and devices; ; “newer presentation” is to be construed in accordance with regulation 3B; ; “older presentation” is to be construed in accordance with regulation 3B(4) and (5); ; “originator” means, in relation to an active ingredient, or in the case of a combination medicine the combination of active ingredients, of a relevant medicine for a presentation— the person who— received the first marketing authorisation for the virtual therapeutic moiety of that active ingredient or combination of active ingredients, or is not the same as the person specified in paragraph (i) but who holds a valid supplementary protection certificate for the active ingredient or combination of active ingredients; or a person who acquires the ownership of the presentation from a person specified in sub-paragraph (a); ; “originator licensee” means a person, other than an originator, who is marketing a presentation and, during the period the presentation was a newer presentation, was— doing so under a licence from the originator permitting marketing of the relevant medicine; or in the same group as the originator for the relevant medicine; ; “vaccine originator” means, in relation to an active ingredient or a combination of active ingredients of a relevant medicine for a presentation that is a vaccine— the person who— received the first marketing authorisation of any presentation for the applicable virtual therapeutic moiety, is not the same person specified in paragraph (i) but who holds a valid supplementary protection certificate for the active ingredient or combination of active ingredients, or if different from the persons specified in paragraph (i) or (ii), was the first person to place the relevant medicine on the market for health service use and, at the time, the licensing authority designated the presentation to include a new active substance; or a person who acquires the ownership of the presentation from a person specified in sub-paragraph (a); ; “vaccine originator licensee” means a person, other than a vaccine originator, who is marketing a vaccine and was, during the period the presentation is a newer presentation— doing so under a licence from the vaccine originator permitting the marketing of the relevant medicine; or in the same group as the vaccine originator for the relevant medicine; ; “virtual therapeutic moiety” means the abstract representation of an active ingredient or active ingredients of a relevant medicine formulated in the medicines information standard as— a medicinal product; or in the case of a vaccine, an indication or indications; .
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