The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2025

Made: at 3.00 p.m. on 1st September 2025

Laid before Parliament: at 5.05 p.m. on 1st September 2025

Coming into force: 1st October 2025

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 88(1) and (2) and 272(7) and (8) of the National Health Service Act 2006[^f00001].

Citation, commencement, extent and application

1

• (1) These Regulations may be cited as the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2025.

• (2) These Regulations come into force on 1st October 2025.

• (3) These Regulations extend to England and Wales and apply in relation to England only[^f00002].

Amendments to Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004

2

In Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004[^f00003] (drugs, medicines and other substances that may be ordered only in certain circumstances)—

• (a) in column 1 of the table (drugs), in the entry relating to drugs for the treatment of erectile dysfunction, omit “Tadalafil” and “Vardenafil”;

• (b) in column 1 of the table, in the entry relating to drugs for the treatment of erectile dysfunction, after the entry for “Avanafil” insert “Cialis” and “Levitra”;

• (c) in column 2 of the table (patient), in the entry relating to “Oseltamivir (Tamiflu)” omit sub-paragraph (a) in paragraphs (1) and (2) and in the entry relating to “Zanamivir (Relenza)” omit sub-paragraph (a) in paragraph (1).

Signed

Signed by authority of the Secretary of State for Health and Social Care

Karin Smyth — Minister of State — Department of Health and Social Care — at 3.00 p.m. on 1st September 2025

Explanatory note

(This note is not part of the Regulations)

Explanatory Note

These Regulations amend the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 (“the principal Regulations”). The principal Regulations make provision in respect of the drugs, medicines and other substances that may be ordered for patients in the provision of services under a general medical services contract within the meaning of section 84 of the National Health Service Act 2006.

Regulation 2 makes amendments to the table in Schedule 2 to the principal Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances) which restricts the circumstances in which certain drugs, medicines and other substances specified in column 1 of the table may be ordered for the category of patients described in column 2 of the table for the purposes specified in column 3 of the table.

The entry in the table relating to certain drugs which may only be ordered for the treatment of erectile dysfunction in restricted circumstances has been amended so as to remove the generic drugs Tadalafil and Vardenafil, and include the brand names Cialis and Levitra. The effect of this amendment is that the restrictions continue to apply to these branded versions of these two erectile dysfunction drugs.

Regulation 2 also removes the notification requirement in relation to the prescription of the influenza antiviral treatments Oseltamivir and Zanamivir, which has the effect of allowing year-round prescribing of these treatments if the other conditions in column 2 of Schedule 2 are met.

Footnotes

[^f00001]: 2006 c. 41. See section 275(1) of the National Health Service Act 2006 for the meaning given to “regulations” which is relevant to the powers being exercised.

[^f00002]: See section 271(1) of the National Health Service Act 2006, by virtue of which the functions of the Secretary of State being exercised in the making of these Regulations are exercisable only in relation to England.

[^f00003]: S.I. 2004/629. Schedule 2 has been amended by S.I. 2004/3215, 2009/2230, 2010/2389, 2011/680, 2013/363 and 2194, 2014/1625, 2015/1862, 2018/378, 2019/777, 2020/1348, 2021/974, 2023/1071 and 2024/728.