- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
6.—(1) The licensing authority shall—
(a)consider every application for the grant, renewal or variation by them of a traditional herbal registration in accordance with the relevant Community provisions, and (where applicable) the rules of Community law relating to parallel imports, and
(b)grant, renew or vary, or refuse to grant, renew or vary the registration in accordance with those provisions and (where applicable) the rules of Community law relating to parallel imports.
(2) Schedule 2 shall have effect to regulate the procedure for receiving advice and representations before granting, renewing or varying, or refusing to grant, renew, or vary a traditional herbal registration, or after notification of a decision relating to an application to vary such a registration.
(3) A parallel import licence shall, unless previously renewed or revoked, be valid for the period specified in it, but where an application to renew it is made in accordance with regulation 5(6) it shall remain in force pending the decision of the licensing authority on that application.
(4) Subject to paragraph (6), a traditional herbal registration other than a parallel import licence shall, unless previously revoked, be valid for an unlimited period unless—
(a)it has not been renewed on the basis of a re-evaluation by the licensing authority of the risk-benefit balance in accordance with, and on the basis of the data set out in, Article 24(2) of the 2001 Directive; or
(b)it has been so renewed, but the licensing authority considers on justified grounds relating to pharmacovigilance that it should be subject to one additional renewal five years after the date of the first renewal, and it has not yet been subject to that additional renewal.
(5) Subject to paragraph (6), where, by reason of paragraph (4), a traditional herbal registration is not valid for an unlimited period, it shall, unless previously revoked, be valid for a period of five years beginning with the date on which it is granted or was renewed, whichever is the later, but where an application for its renewal is made in accordance with Article 24 of the 2001 Directive the traditional herbal registration shall remain in force pending the decision of the licensing authority on that application.
(6) A traditional herbal registration (other than a parallel import licence) shall cease to be valid if at any time after it is granted the medicinal product to which it relates is not placed on the market in the United Kingdom for a period of three consecutive years, unless an exemption is granted in accordance with Article 24(6) of the 2001 Directive.
(7) Each traditional herbal registration granted by the licensing authority shall be granted subject to a condition that the traditional herbal medicinal product to which the registration relates is to be available—
(a)only from a pharmacy; or
(b)on general sale.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: