Medicines Act 1968

Applications for, and grant and renewal of, licencesU.K.

18 Application for licence. U.K.

(1)Any application for the grant of a licence under this Part of this Act shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as may be prescribed.

(2)Any such application shall indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.

F1(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19 Factors relevant to determination of application for licence. U.K.

(1)Subject to the following provisions of this Part of this Act, in dealing with an application for a product licence the licensing authority shall in particular take into consideration—

(a)the safety of medicinal products of each description to which the application relates;

(b)the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered; and

(c)the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality.

(2)In taking into consideration the efficacy for a particular purpose of medicinal products of a description to which such an application relates, the licensing authority shall leave out of account any question whether medicinal products of another description would or might be equally or more efficacious for that purpose:

(3)Where any such application indicates that the purposes for which the licence is required relate (wholly or partly) to medicinal products which have been or are to be imported, then in dealing with the application, in so far as it relates to such products, the licensing authority shall also take into consideration in particular the methods, standards and conditions of manufacture of those products and may, if they think fit, require the production by the applicant of any one or more of the following, that is to say—

(a)an undertaking, given by the manufacturer of any such products, to permit the premises where they are or are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the licensing authority;

(b)an undertaking, given by or on behalf of the manufacturer of any such products, to comply with any prescribed conditions or any conditions attached to the licence by the licensing authority;

(c)a declaration, given by or on behalf of the manufacturer of any such products, that, in relation to the manufacture of those products, any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with.

(4)Where any such application indicates that the purposes for which the license is required relate exclusively to the exportation of medicinal products, the licensing authority shall leave out of account considerations of safety and efficacy (as mentioned in paragraphs (a) and (b) of subsection (1) of this section) if satisfied that in the circumstances it is reasonable to do so.

(5)In dealing with an application for a manufacturer’s licence the licensing authority shall in particular take into consideration—

(a)the operations proposed to be carried out in pursuance of the licence:

(b)the premises in which those operations are to be carried out;

(c)the equipment which is or will be available on those premises for carrying out those operations;

(d)the qualifications of the persons under whose supervision those operations will be carried out; and

(e)the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.

(6)In dealing with an application for a wholesale dealer’s licence the licensing authority shall in particular take into consideration—

(a)the premises on which medicinal products of the descriptions to which the application relates will be stored;

(b)the equipment which is or will be available for storing medicinal products on those premises;

(c)the equipment and facilities which are or will be available for distributing medicinal products from those premises; and

(d)the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored on or distributed from those premises.

(7)The preceding provisions of this section shall have effect subject to the provisions of this Part of this Act relating to licences of right.

20 Grant or refusal of licence. U.K.

(1)Subject to [F2sections 8(2E) and (3E) and 19,], and to the following provisions of this Act, on any application to the licensing authority for a licence under this Part of this Act the licensing authority—

(a)may grant a licence containing such provisions as they consider appropriate, or

(b)if, having regard to the provisions of this Act [F3and any Community obligation], they consider it necessary or expedient to do so, may refuse to grant a licence.

[F4(1A)The licensing authority must either grant or refuse any application for a licence under this Part, before the end of a period of 90 days from the date upon which they receive the application.]

[F4(2B)If there are requirements in force under section 18 that apply to the application, subsection (1A) applies only if the requirements have been met]

[F4(2C)If a notice under section 44 requires the applicant to provide the licensing authority with information, the period specified in subsection (1) stops running when the notice is given, and does not start running again until—

(a)the licensing authority receives the information; or

(b)the applicant has shown to the reasonable satisfaction of the licensing authority why he is unable to provide it.]

(2)The licensing authority shall not refuse to grant such a licence on any grounds relating to the price of any product, and shall not insert in any such licence any provisions as to the price at which any product may be sold, supplied, imported or exported.

(3)The licensing authority shall not refuse to grant such a licence on any grounds relating to the safety, quality or efficacy of medicinal products of any description, except after consultation with the appropriate committee F5....

F6(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5)Where on an application for a licence under this Part of this Act—

(a)the licensing authority refuse to grant a licence, or

(b)the licensing authority grant a licence otherwise than in accordance with the application, and the applicant requests the licensing authority to state their reasons,

the licensing authority shall serve on the applicant a notice stating the reasons for their decision.

[F721 Procedure on reference to appropriate committee U.K.

(1)Where the appropriate committee are consulted under section 20(3) of this Act and are of the provisional opinion that, on grounds relating to safety, quality or efficacy, they—

(a)may be unable to advise the licensing authority to grant the licence; or

(b)may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application,

they shall notify the applicant accordingly.

(2)A person who has been so notified may, within the time allowed, give notice of his wish to make written or oral representations to the appropriate committee.

(3)The appropriate committee shall give the applicant an opportunity to make such representations in accordance with subsections (4) to (7) of this section.

(4)Subject to subsection (5) of this section, the applicant shall provide the appropriate committee with—

(a)his written representations or a written summary of the oral representations he intends to make; and

(b)any documents on which he wishes to rely in support of those representations,

before the end of the period of six months beginning with the date of the notice referred to in subsection (2) of this section, or within such shorter period as the appropriate committee may specify in the notification under subsection (1).

(5)If the applicant so requests, the appropriate committee may extend the time limit referred to in subsection (4) of this section, up to a maximum period of twelve months beginning with the date of the notice referred to in subsection (2) of this section.

(6)The applicant may not submit any additional written representations or documents once the time limit referred to in subsections (4) and (5) of this section has expired, except with the permission of the appropriate committee.

(7)If the applicant gave notice of his wish to make oral representations, the appropriate committee shall, after receiving a written summary and any other documents in accordance with subsection (4) of this section, arrange for the applicant to make such representations at a hearing before the committee.

(8)The appropriate committee shall—

(a)take into account such representations as are made in accordance with this section; and

(b)report their findings and advice to the licensing authority, together with the reasons for their advice.

(9)After receiving the report of the appropriate committee, the licensing authority shall—

(a)decide whether to grant or refuse the application, or to grant it otherwise than in accordance with the application; and

(b)take the report into account when making their decision.

(10)The licensing authority shall notify the applicant of—

(a)the decision made pursuant to subsection (9) of this section; and

(b)the advice given to them by the appropriate committee and the reasons for that advice.

(11)If—

(a)the applicant has made representations in accordance with this section and the licensing authority have notified the applicant of the authority’s decision to refuse to grant the licence, or to grant it otherwise than in accordance with the application; or

(b)the applicant has not made representations in accordance with this section and the licensing authority have notified the applicant of the authority’s decision to refuse to grant the licence, or to grant it otherwise than in accordance with the application, on grounds which differ from those relied on in the advice of the appropriate committee,

the applicant may, within the time allowed, notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision.

(12)In this Part of the Act, “the time allowed” means the period of twenty-eight days beginning with the date of the relevant notification, or such longer period as the licensing authority may allow in any particular case.]

[F8 22 Procedure in other cases. U.K.

(1)This section applies when—

(a)an application is made for the grant of a licence under this Part of this Act; and

(b)the appropriate committee—

(i)is not consulted under subsection (3) of section 20, or

(ii)is consulted under that subsection but does not give a provisional opinion in accordance with section 21(1).

(2)If the licensing authority propose—

(a)to refuse to grant the licence, or

(b)to grant it otherwise than in accordance with the application,

they shall notify the applicant of their proposals and the reasons for them.

(3)If the applicant is so notified, he may, within the time allowed—

(a)notify the licensing authority of his wish to appear before and be heard by a person appointed by the licensing authority with respect to the proposal; or

(b)make representations in writing to the licensing authority with respect to the proposal referred to in the notification.

(4)If the applicant makes written representations in accordance with subsection (3)(b) of this section, the licensing authority shall take those representations into account before determining the application.

22A .Hearing before person appointedU.K.

(1)If the applicant gives notice under section 21(11) or section 22(3) of his wish to appear before and be heard by a person appointed by the licensing authority, the authority shall—

(a)make that appointment; and

(b)arrange for the applicant to have an opportunity of appearing before that person.

(2)The person appointed—

(a)shall not be, or at any time have been, a member of—

(i)the Commission on Human Medicines or any of its Expert Advisory Groups,

(ii)the Medicines Commission formerly established under section 2 of this Act or any of its committees, or

(iii)a committee established under section 4 of this Act, or any sub-committee of such a committee; and

(b)shall not be an officer or servant of any Minister of the Crown.

(3)Subject to subsection (4) of this section, the applicant shall provide the person appointed with—

(a)a written summary of the oral representations he intends to make; and

(b)any documents on which he wishes to rely in support of those representations,

before the end of the period of three months beginning with the date of the notice referred to in subsection (1) of this section.

(4)If the applicant so requests, the person appointed may, after consulting the licensing authority, extend the time limit referred to in subsection (3) of this section, up to a maximum period of six months beginning with the date of the notice referred to in subsection (1) of this section.

(5)If the applicant fails to comply with the time limit in subsection (3) of this section, or, where he has been granted an extended time limit under subsection (4) of this section, that time limit—

(a)he may not appear before or be heard by the person appointed, and

(b)the licensing authority shall decide whether to grant or refuse the licence, or to grant it otherwise than in accordance with the application, and notify the applicant accordingly.

(6)The applicant may not submit any additional written representations or documents once the time limit has expired, except with the permission of the person appointed.

(7)At the hearing before the person appointed, both the applicant and the licensing authority may make representations.

(8)If the applicant so requests the hearing shall be in public.

(9)After the hearing—

(a)the person appointed shall provide a report to the licensing authority; and

(b)the licensing authority shall take the report into account and decide whether to grant or refuse the licence, or to grant it otherwise than in accordance with the application, or to confirm or alter their decision, as the case may be.

(10)The licensing authority shall then—

(a)notify the applicant of their decision;

(b)if the applicant so requests, provide the applicant with a copy of the report of the person appointed.]

23 Special provisions as to effect of manufacturer’s licence. U.K.

(1)Subject to F9...F10F9... the following provisions of this section, a manufacturer’s licence shall not have effect so as to authorise the manufacture or assembly of medicinal products of any description for sale or supply to any other person, or for exportation, unless either—

(a)the holder of the licence is also the holder of a product licence which is applicable to medicinal products of that description, or

[F11(b)the products are manufactured or assembled to the order of—

(i)a person who is the holder of such a product licence, or

(ii)if the products are to be used for the purposes of a clinical trial, the sponsor of that trial,]

and (in either case) the products are manufactured or assembled in accordance with that product licence.

(2)F12... the preceding subsection shall not have effect in relation to the manufacture or assembly of any medicinal product to the order of a practitioner, where the practitioner—

(a)being a doctor or dentist, states that the product is required for administration to a patient of his or is required, at the request of another doctor or dentist, for administration to a patient of that other doctor or dentist, F13...

F13(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and shall not have effect in relation to the manufacture or assembly of any medicinal product to the order of a pharmacist in accordance with a prescription given by a practitioner.

F14(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)If by virtue of an order made under section 15 of this Act an exemption is conferred in respect of the restrictions imposed by section 7 of this Act, but no corresponding exemption is conferred in respect of the restrictions imposed by section 8(2) of this Act, the order may provide that subsection (1) of this section shall have effect subject to such exceptions or modifications as the Ministers consider appropriate in the circumstances.

(5)Where subsection (1) of this section has effect in relation to medicinal products of any description, and the conditions specified in that subsection are not fulfilled, the manufacture or assembly of medicinal products of that description for sale or supply to another person, or for exportation, notwithstanding that it complies with the provisions contained in the manufacturer’s licence, shall for the purposes of this Act be deemed to be not in accordance with that licence.

[F15(6)In this section, “clinical trial” and “sponsor”, in relation to a clinical trial, have the meaning given by Clinical Trials Regulations.]

24 Duration and renewal of licence. U.K.

[F16(1)A licence granted under this Part expires—

(a)in accordance with the provisions of the licence, or

(b)if there is no such provision, at the end of the period of five years beginning with the date on which the licence was granted, or if it has been renewed the date on which it was last renewed.

(1AA)But so far as the licence relates to a medicinal product to which the 2001 Directive applies, it remains in force until—

(a)revoked by the licensing authority; or

(b)surrendered by the holder.]

(2)Any [F17licence granted under this Part of this Act], if it has not been revoked, may, on the application of the holder of the licence, be renewed by the licensing authority for a further period of five years from the date on which it would otherwise expire or such shorter period from that date as the licensing authority may determine.

[F18(2A)Subsection (2) does not apply to a licence insofar as it relates to a medicinal product to which the 2001 Directive applies.]

(3)On an application to the licensing authority for the renewal of a licence under this Part of this Act, the licensing authority—

(a)may renew the licence, with or without modifications, for such a further period as is mentioned in subsection (2) of this section, or

(b)may grant to the applicant a new licence containing such provisions as the licensing authority consider appropriate, or

(c)if, having regard to the provisions of this Act [F19and any Community obligation under [F20the 2001 Directive other than Titles VI, VII and VIII of that Directive]], they consider it necessary or expedient to do so, may refuse to renew the licence or to grant a new licence.

[F21(3A)References to a licence in subsection (3) are to be read as references to a licence only insofar as that licence relates to a medicinal product to which the 2001 Directive does not apply.]

(4)In relation to any such application the provisions of sections 18 and 19, subsections (2) to (5) of section 20 and sections [F2221 to 22A] of this Act shall have effect as if in those provisions any reference to refusing a licence included a reference to refusing to renew a licence and any reference to granting a licence included a reference to renewing it.

(5)Every application for the grant or renewal of a licence under this Part of this Act shall, unless it otherwise expressly provides, be taken to be an application for the grant or renewal of the licence for the full period of five years mentioned in subsection (1) or subsection (2) of this section, as the case may be; and in this Part of this Act any reference (including a reference implied by virtue of the last preceding subsection) to the grant or renewal of a licence otherwise than in accordance with the application shall be construed accordingly.

[F23(5A)Subsection (5) does not apply to a licence insofar as it relates to a medicinal product to which the 2001 Directive applies.]

(6)Where an application for the renewal of a licence under this Act has been duly made—

(a)the licence shall not cease to be in force by virtue of the preceding provisions of this section before the licensing authority have determined the application, and

(b)if by an interim order made under section 107(3)(a) of this Act the operation of the decision of the licensing authority on the application is suspended, the licence shall not cease to be in force by virtue of those provisions so long as the operation of the decision continues to be suspended by the order.

F24(7). . .