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Part IIE+W+S+N.I. Licences and Certificates Relating to Medicinal Products

General provisions and exemptionsE+W+S+N.I.

F16 The licensing authority. E+W+S+N.I.

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F17 General provisions as to dealing with medicinal products. E+W+S+N.I.

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F18 Provisions as to manufacture and wholesale dealing. E+W+S+N.I.

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F1 9 Exemptions for doctors and dentists E+W+S+N.I.

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10 Exemptions for pharmacists. E+W+S+N.I.

(1)F2 ... the restrictions imposed by [F3regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy, a hospital [F4 , a care home service ] or a health centre and is done there by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product in accordance with a prescription given by [F5an appropriate practitioner], or

(b)assembling a medicinal product [F6provided that where the assembling takes place in a registered pharmacy—

(i)it shall be in a registered pharmacy at which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at that registered pharmacy or at any other such registered pharmacy forming part of the same retail pharmacy business, and

(ii)the medicinal product has not been the subject of an advertisement]; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.

F7( 2 ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3)Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a) the product is prepared or dispensed for administration to that person or to a person under his care, F8 ...

F8( b ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Without prejudice to the preceding subsections, the restrictions imposed by [F9 regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a)preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or

(b)preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection [F10provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at that registered pharmacy or at any other registered pharmacy forming part of the same retail pharmacy business];

and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.

[F11(5) Without prejudice to the preceding subsections, the restrictions imposed by [F12 regulation 46 of the 2012 Regulations] do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

(a)the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and

(b)the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at the registered pharmacy at which it is prepared, and

(c)the medicinal product has not been the subject of an advertisement.

(6) Without prejudice to the preceding subsections, the restrictions imposed by [F13 regulation 17(1) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at that registered pharmacy.

F14( 6A ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15( 7 ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F16(7A) The F17 ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

(7B)Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

(7C)In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.]

(8) For the purposes of this section “advertisement" shall have the meaning assigned to it by [F18 regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations] . ]

[F19(9) In subsection (1) of this section, “care home service" has the meaning given by [F20 paragraph   2 of schedule   12 to the Public Services Reform (Scotland) Act 2010 (asp   8) ] . ]

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Amendments (Textual)

F2Words in s. 10(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(a) (with regs. 2(4), 3)

F4Words in s. 10(1) inserted (S.) (1.4.2002) by 2001 asp 8, s. 79, Sch. 3 para. 5(a); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

F6Words added by S.I. 1971/1445, art. 3(a)

F11S. 10(5)–(8) added by S.I. 1971/1445, art. 3(c)

F15S. 10(7) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(e) Sch. 35 (with Sch. 32)

F16S. 10(7A)-(7C) inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 26(1), 83(1)(e)

F17Word in s. 10(7A) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(e) (with regs. 2(4), 3)

F19S. 10(9) added (S.) (1.4.2002) by 2001 asp 8, ss. 79, Sch. 3 para. 5(b); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

Modifications etc. (not altering text)

C1Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C2S. 10 amended (E.W.S.) (prosp) by 1954 c. 61, s. 13I(1)(b) (as inserted (prosp.) by 1997 c. 19, ss. 1, 2(1), Sch. para. 2)

F2111 Exemption for nurses and midwives. E+W+S+N.I.

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F2112 Exemptions in respect of herbal remedies. E+W+S+N.I.

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F2113 Exemptions for imports. E+W+S+N.I.

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F21 14 Exemption for re-exports. E+W+S+N.I.

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15 Provision for extending or modifying exemptions. E+W+S+N.I.

F22(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F22(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The F23 ... Ministers may by order provide that any of the provisions of [F24 section 10 ] of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.

(4)No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Annotations:

Amendments (Textual)

F22S. 15(1)(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 4(a) Sch. 35 (with Sch. 32)

F23Word in s. 15(3) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(b) (with regs. 2(4), 3)

F24Words in s. 15(3) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 4(b) Sch. 35 (with Sch. 32)

Modifications etc. (not altering text)

C3 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403 , art. 3(1)

F2516 Transitional exemptions. E+W+S+N.I.

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F2517 Termination of transitional exemptions. E+W+S+N.I.

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Applications for, and grant and renewal of, licencesE+W+S+N.I.

F2518 Application for licence. E+W+S+N.I.

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F2519 Factors relevant to determination of application for licence. E+W+S+N.I.

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F2520 Grant or refusal of licence. E+W+S+N.I.

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F25 21 Procedure on reference to appropriate committee E+W+S+N.I.

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F25 22 Procedure in other cases. E+W+S+N.I.

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F25 22A .Hearing before person appointedE+W+S+N.I.

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F2523 Special provisions as to effect of manufacturer’s licence. E+W+S+N.I.

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F2524 Duration and renewal of licence. E+W+S+N.I.

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Licences of rightE+W+S+N.I.

F2525 Entitlement to licence of right. E+W+S+N.I.

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F2626 Scope of licence of right in different cases. E+W+S+N.I.

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F26S. 26 repealed (22.7.2004) by Statute Law (Repeals) Act 2004 (c. 14), Sch. 1 Pt. 17 Group 7

F2527 Proceedings on application for licence of right. E+W+S+N.I.

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Suspension, revocation and variation of licencesE+W+S+N.I.

F2528 General power to suspend, revoke or vary licences. E+W+S+N.I.

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F2529 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.E+W+S+N.I.

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F2530 Variation of licence on application of holder. E+W+S+N.I.

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Clinical trials and medicinal tests on animalsE+W+S+N.I.

F2731 Clinical trials. E+W+S+N.I.

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F2832 Medicinal tests on animals. E+W+S+N.I.

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F2833 Exemptions in respect of medicinal tests on animals. E+W+S+N.I.

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F2834 Restrictions as to animals on which medicinal tests have been carried out. E+W+S+N.I.

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F2835 Supplementary provisions as to clinical trials and medicinal tests on animals.E+W+S+N.I.

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F2836 Application for, and issue of, certificate. E+W+S+N.I.

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F2937 Transitional provisions as to clinical trials and medicinal tests on animals. E+W+S+N.I.

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F29S. 37 repealed (22.7.2004) by Statute Law (Repeals) Act 2004 (c. 14), Sch. 1 Pt. 17 Group 7

F3038 Duration and renewal of certificate. E+W+S+N.I.

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F3039 Suspension, revocation or variation of certificate. E+W+S+N.I.

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Medicated animal feeding stuffsE+W+S+N.I.

F3040 Medicated animal feeding stuffs. E+W+S+N.I.

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41–42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F31E+W+S+N.I.

Supplementary provisionsE+W+S+N.I.

F2543 Extension of s. 7 to certain special circumstances. E+W+S+N.I.

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F2544 Provision of information to licensing authority. E+W+S+N.I.

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F2545 Offences under Part II. E+W+S+N.I.

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F2546 Special defences under s. 45. E+W+S+N.I.

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F2547 Standard provisions for licences E+W+S+N.I.

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F2548 Postponement of restrictions in relation to exports. E+W+S+N.I.

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F2549 Special provisions in respect of exporting certain products. E+W+S+N.I.

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F32 49A Special provisions in respect of exporting certain products to member States E+W+S+N.I.

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F2549B. Special provisions in respect of exporting certain products to EEA State s E+W+S+N.I.

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F2550 Certificates for exporters of medicinal products. E+W+S+N.I.

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