- Latest available (Revised)
- Original (As made)
There are currently no known outstanding effects for the The Human Medicines Regulations 2012, Cross Heading: Consideration of application.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
130.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a traditional herbal registration before the end of the period of 210 days beginning immediately after the day on which an application for the registration is submitted in accordance with regulation 128.
(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—
(a)beginning with the date on which the request is made; and
(b)ending with the date on which the information or material is provided.
(3) If the licensing authority requests the applicant to give an oral or written explanation of the application, the period referred to in paragraph (1) is suspended for the period—
(a)beginning with the date on which the request is made; and
(b)ending with the date on which the explanation is provided.
(4) The licensing authority may grant the application only if, having considered the application and the accompanying material, the authority thinks that—
(a)the product complies with conditions A to E of regulation 125 (conditions for a product to be a traditional herbal medicinal product);
(b)the product to which the application relates is not harmful under normal conditions of use;
(c)the application and the accompanying material complies with the requirements of this Part;
(d)the product's qualitative and quantitative composition is as described in the application and the accompanying material; and
(e)the product's pharmaceutical quality has been satisfactorily demonstrated.
(5) The licensing authority need not take into account any updated information supplied in connection with the application under regulation 129 (obligation to update information supplied in connection with application), unless it thinks that the information is unfavourable in respect of the safety, quality or efficacy of the product concerned
(6) The licensing authority may refuse the application on the ground that it is more appropriate to consider whether to authorise the placing of the product on the market in response to an application for a [F1UK] marketing authorisation or certificate of registration for the product.
(7) Paragraph (4)(a)
[F2(a)where the application is for a THR(NI) or THR(UK), is subject to Article 16c(4) of the 2001 Directive (procedure where product has been used in the European Union for less than 15 years);
(b)where the application is for a THR(GB), is subject to regulation 130A.]
(8) If the application relates to a herbal medicinal product that is contained in the list referred to Article 16f(1) of the 2001 Directive [F3where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)]—
(a)paragraph (4)(a) applies as if it referred to conditions A to D of regulation 125; and
(b)paragraph (4)(b) does not apply.
(9) Where [F4, in relation to an application for a THR(NI) or THR(UK),] Article 16d(1) of the 2001 Directive (products to which the mutual recognition procedure and decentralised procedure apply) does not apply to the product, the licensing authority must, in considering the application, take into account any registrations granted by other member States in accordance with Chapter 2a of Title III of the 2001 Directive.
(10) The licensing authority must take into account—
(a)any herbal monograph of the kind referred to [F5—
(i)in Article 16h(3) of the 2001 Directive, where the application is for a THR(NI) or THR(UK);
(ii)in regulation 143A, where the application is for a THR(GB),
that the authority thinks relevant to the application; or]
(b)if no relevant monograph within sub-paragraph (a) has been established, such other monographs, publications or data as the authority thinks relevant.
(11) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a traditional herbal registration.
(12) This regulation does not apply where [F6, in relation to an application for a THR(NI) or THR(UK),] Article 16d(1) applies to the product and the application—
(a)has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive; or
(b)has been referred to the Committee for Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.
(13) An application to which paragraph (12) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.
[F7(14) In the case of an application under the unfettered access route, the licensing authority may grant a THR(GB) (notwithstanding paragraph (4)) where the licensing authority—
(a)has considered the application under the unfettered access route and the accompanying material,
(b)is satisfied that the applicant has complied with the application requirements, and
(c)is satisfied that the conditions in regulation 127(1A) will continue to be met.
(15) The licencing authority may refuse to grant an application under the unfettered access route where it is of the opinion that it would represent a risk to public health to do so.]
Textual Amendments
F1Word in reg. 130(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 116(2); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 130(7)(a)(b) substituted for words in reg. 130(7) (31.12.2020) by S.I. 2019/775, reg. 116(3) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(a)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 130(8) inserted (31.12.2020) by S.I. 2019/775, reg. 116(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(b)) 2020 c. 1, Sch. 5 para. 1(1)
F4Words in reg. 130(9) inserted (31.12.2020) by S.I. 2019/775, reg. 116(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(c))
F5Reg. 130(10)(a)(i)(ii) substituted for words in reg. 130(10)(a) (31.12.2020) by S.I. 2019/775, reg. 116(6) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(d)); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in reg. 130(12) inserted (31.12.2020) by S.I. 2019/775, reg. 116(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(e))
F7Reg. 130(14)(15) inserted (31.12.2020) by S.I. 2019/775, reg. 116(8) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 87(f))
130A.—(1) Where an application for a THR(GB) (other than an application under the unfettered access route) has been made and the licensing authority considers that—
(a)the traditional herbal medicinal product does not satisfy regulation 125(5)(b) (Condition D); but
(b)otherwise satisfies the conditions in regulation 125,
the licensing authority may refer the matter to the appropriate committee for relevant advice, and the procedure in Part 3 of Schedule 11 applies (referral to the appropriate committee for traditional herbal registrations).
(2) In this regulation—
“appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11;
“relevant advice” means advice as to whether—
the conditions in regulation 125, other than condition D, are met in relation to the application; and
the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.]
Textual Amendments
F8Reg. 130A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 117 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 88); 2020 c. 1, Sch. 5 para. 1(1)
131.—(1) A traditional herbal registration must include a term that the product to which the registration relates is to be available—
(a)only from a pharmacy; or
(b)on general sale.
(2) A traditional herbal registration may include a term that the product to which the registration relates is to be available on general sale only if the licensing authority considers that the product can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist.
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
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.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
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:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
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: