Medicines Act 1968

Establishment of Medicines Commission.

New editions of British Pharmacopoeia, and other compendia.

Rights of entry.

Special provisions as to Northern Ireland.

The Cancer Act 1939 (c. 13.)

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General provisions.

Scope of Part VI.

False or misleading advertisements and representations.

Exemptions for pharmacists.

Enforcement in Northern Ireland.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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SCHEDULE 1A

1

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2

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3

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4

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5

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6

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7

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8

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9

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10

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11

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12

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2A

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Provisions as to manufacture and wholesale dealing.

Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners.

Hearing before person appointed

22A

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Special provisions as to effect of manufacturer’s licence.

Special provisions in respect of exporting certain products to EEA States

49B

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Exemption for nurses and midwives.

Duration and renewal of licence.

Hearing before person appointed

False or misleading advertisements and representations.

Duration and renewal of licence.

Certificates for exporters of medicinal products.

General provisions as to operation of Act.

Procedure in other cases

Hearing before person appointed

The Venereal Disease Act 1917 (c. 21).

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Provisions as to manufacture and wholesale dealing.

Exemptions for pharmacists.

Hearing before person appointed

Certificates for exporters of medicinal products.

Scope of licence of right in different cases.

Business carried on by individual pharmacist or by partners.

Scope of Part VI.

Special provisions in respect of exporting certain products to EEA States

Requirement to specify certain products as prescription-only products

Rights of entry.

Protection of purchasers of medicinal products.

Hearing before person appointed

Special provisions as to effect of manufacturer’s licence.

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Representative of pharmacist in case of death or disability.

Requirement to specify certain products for veterinary use as prescription-only products.

General provisions as to operation of Act.

General interpretation provisions.

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72A

• (A1) Nothing in this Part is to be taken as requiring there to be a responsible pharmacist in respect of premises at or from which a retail pharmacy business is carried on at a time when no medicinal products (whether they are on a general sale list or not) are being—

• (a) offered or exposed for sale by retail or supply in circumstances corresponding to retail sale at or from the premises, or

• (b) assembled, prepared or dispensed at or from the premises with a view to such sale or supply.

• (1) It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy business carried on at or from the premises in question so far as concerns—

• (a) the retail sale at or from those premises of medicinal products (whether they are on a general sale list or not), and

• (b) the supply at or from those premises of such products in circumstances corresponding to retail sale.

• (2) A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by the General Pharmaceutical Council in rules in relation to premises in Great Britain or the Council of the Pharmaceutical Society of Northern Ireland in regulations in relation to premises in Northern Ireland, and then only if such conditions as may be so specified are complied with.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) The General Pharmaceutical Council may make further provision in rules in relation to the responsible pharmacist in respect of premises in Great Britain, and the Council of the Pharmaceutical Society of Northern Ireland may make further provision in regulations in relation to the responsible pharmacist in respect of premises in Northern Ireland.

• (6A) In making any such provision, the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland must have regard to the principle that the burdens imposed on businesses by rules or regulations should be the minimum necessary to secure the benefits, considered in general terms, which are expected to result from the rules or regulations.

• (7) The rules and regulations mentioned in subsection (6) may (amongst other things)—

• (a) make further provision about the matters mentioned in subsection (1);

• (b) make provision about the responsible pharmacist’s absence from the premises.

• (7A) If such rules or regulations make provision about the responsible pharmacist’s absence from the premises, they must also provide that the retail sale of medicinal products on a general sale list may continue at or from the premises during any period in which the responsible pharmacist is absent from the premises.

• (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

72B

• (1) The failure by a person to comply with any requirements of section 72A or 72AA of this Act, or of rules or regulations made under section 72A, may constitute misconduct for the purposes of section 80 of this Act, article 51(1)(a) of the Pharmacy Order 2010 and Article 20 of the Pharmacy (Northern Ireland) Order 1976 and the relevant disciplinary committee may deal with such a failure accordingly.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) Subsection (4) of this section applies if a person—

• (a) fails to comply with the requirements of subsection (2) of section 72A of this Act, or of rules or regulations made under that subsection,

• (b) fails to comply with any requirements as to absence from the premises contained in rules or regulations made by virtue of subsection (7) of that section.

• (4) If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of the business carried on at or from the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act.

Scope of Part VI.

Medicinal products on prescription only.

New editions of British Pharmacopoeia, and other compendia.

Rights of entry.

Facilities for microbiological examinations.

Transitional exemptions.

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Certificates for exporters of medicinal products.

The Cancer Act 1939 (c. 13.)

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Provisions as to manufacture and wholesale dealing.

Exemptions for pharmacists.

Exemptions for pharmacists.

Hearing before person appointed

Medicinal products on prescription only.

Entitlement to licence of right.

Medicinal products on prescription only.

Protection of purchasers of medicinal products.

General provisions.

Exemptions for imports.

The responsible pharmacist

Power to extend or modify conditions.

False or misleading advertisements and representations.

Adulteration of medicinal products.

Special provisions in respect of exporting certain products to EEA States

Enforcement in Scotland.

Enforcement in Scotland.

Power to inspect, take samples and seize goods and documents.

Transitional exemptions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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General provisions.

Exemption for re-exports.

Provision for extending or modifying exemptions.

General provisions.

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Representative of pharmacist in case of death or disability.

Transitional exemptions.

Termination of transitional exemptions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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Power for relevant disciplinary committee to disqualify and direct removal from register.

The responsible pharmacist

Rules by the General Pharmaceutical Council

Provision for modifying or extending restrictions under s. 78.

Special provisions in respect of exporting certain products to EEA State s

Enforcement in Scotland.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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Duration and renewal of licence.

Sale of medicinal products from automatic machines.

Certificates for exporters of medicinal products.

Special provisions in relation to new medicinal products.

Exemption for nurses and midwives.

Bodies corporate.

Revocation of disqualification.

Sale or supply of medicinal products on general sale list.

Scope of Part VI.

Requirement to specify certain products as prescription-only products

Advertisements requiring consent of holder of product licence.

Certificates for exporters of medicinal products.

General interpretation provisions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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The responsible pharmacist

Provision for extending or modifying exemptions.

Scope of Part VI.

Business carried on by body corporate

New editions of British Pharmacopoeia, and other compendia.

Power to inspect, take samples and seize goods and documents.

Enforcement in Northern Ireland.

Meaning of “medicinal product" and related expressions.

Exemptions for imports.

General interpretation provisions.

Special provisions as to Northern Ireland.

The Cancer Act 1939 (c. 13.)

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74A

• (1) This section applies in relation to premises in Great Britain.

• (2) If the registrar is satisfied that the conditions in section 74B are met in relation to premises that are not entered in the register, the registrar must enter the premises in Part 3 of the register unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

• (3) Subject to subsection (5) and to section 74H, the entry of premises entered in Part 3 of the register under subsection (2) is valid for the period of one year beginning with the date on which the entry was made.

• (4) If the registrar is satisfied that the conditions in section 74B are met in relation to premises entered in Part 3 of the register under subsection (2), the registrar must renew the entry of the premises unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

• (5) Subject to subsection (7) and to section 74H, each renewal of the entry of premises entered in Part 3 of the register under subsection (2) extends the validity of the entry for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid.

• (6) The registrar may, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, renew the entry of premises in Part 3 of the register for a period exceeding one year beginning with the day on which the entry would otherwise have ceased to be valid in which case the renewal of the entry of premises entered in that part of the register under subsection (2) extends the validity of the entry for that period.

• (7) If the entry of premises entered in Part 3 of the register under this section ceases to be valid then, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, the premises are to be treated for all purposes as no longer being entered in Part 3 of the register and accordingly the registrar must remove the entry from that part of the register.

74B

• (1) The conditions referred to in section 74A are as follows.

• (2) Condition A is that an application for the entry of the premises in Part 3 of the register or, as the case may be, for the renewal of the entry of the premises in Part 3 of the register is made—

• (a) in such form and manner as is prescribed in rules made by the General Pharmaceutical Council; and

• (b) if the application is an application for renewal, by such time prior to the entry ceasing to be valid as is so prescribed.

• (3) Condition B is that the appropriate fee prescribed in rules made by the General Pharmaceutical Council under article 36(1) of the Pharmacy Order 2010 is paid.

• (4) Condition C—

• (a) if the application is an application for the entry of the premises in Part 3 of the register, is that either—

• (i) the applicant is lawfully conducting a retail pharmacy business, or

• (ii) if the premises are entered in Part 3 of the register, and the applicant begins to carry on a retail pharmacy business at or from the premises, the applicant will, from the time the applicant begins to do so, be a person lawfully conducting a retail pharmacy business; or

• (b) if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is that the applicant is lawfully conducting a retail pharmacy business at or from the premises.

• (5) Condition D—

• (a) if the application is an application for the entry of the premises in Part 3 of the register, is that the standards that are provided for in rules made set under article 7(1) of the Pharmacy Order 2010 are met, or are capable of being met, in connection with the carrying on of a retail pharmacy business at or from the premises; or

• (b) if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is—

• (i) that the standards that are provided for in rules made set under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at or from the premises, and

• (ii) that the requirements of rules (if any) made under article 7(4) of that Order are met by the person carrying on a retail pharmacy business at or from the premises.

74C

• (1) The registrar may restore to Part 3 of the register the entry of premises removed from that part of the register by virtue of section 74A(7) if an application is made to the registrar in accordance with this section.

• (2) An entry restored under this section to Part 3 of the register—

• (a) is still to be treated as having been entered in that part of the register under section 74A;

• (b) is valid for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid by virtue of section 74A(7) or is valid for such longer period beginning with that day as the registrar may in any particular case allow; and

• (c) may be subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of section 74A(7) or may be subject to such other conditions as the registrar may impose under section 74D(1).

• (3) An application for restoration may be made to the registrar by the person who is the owner of the retail pharmacy business previously carried on at or from the premises and that person must be—

• (a) a person who is lawfully conducting a retail pharmacy business; or

• (b) a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at or from the premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

• (4) The General Pharmaceutical Council may make rules in connection with applications under this section.

• (5) Rules under subsection (4) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

• (b) about the information to be provided in respect of applications; and

• (c) about the circumstances in which applications must or, as the case may be, may be refused (including where an application for renewal under this section was not received by the registrar by the time prescribed by the General Pharmaceutical Council in rules under section 74B(2)(b)).

• (6) Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under this section, the registrar must give notice in writing of that restoration to the applicant.

• (7) The notice under subsection (6) must specify—

• (a) the period for which the entry restored to Part 3 of the register is valid;

• (b) any conditions to which that entry is subject by virtue of subsection (2)(c).

• (8) The notice under subsection (6) must be sent—

• (a) where the retail pharmacy business was carried on by an individual, to that individual at that individual’s home address in the register;

• (b) where the retail pharmacy business was carried on by a partnership, to that partnership at its principal office;

• (c) where the retail pharmacy business was carried on by a body corporate, to that body corporate at its registered or principal office.

74D

• (1) The registrar may make the entry of premises entered in Part 3 of the register under section 74A subject to such conditions as the registrar considers it necessary to impose for the purpose of securing the safe and effective practice of pharmacy in the course of the business carried on at or from those premises.

• (2) The power under subsection (1)—

• (a) may be exercised on the making of the entry or subsequently (whether on a renewal of the entry or otherwise);

• (b) includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

• (3) Except as provided in subsection (4), the registrar may not under subsection (1)—

• (a) impose a new condition in respect of premises already entered in Part 3 of the register; or

• (b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on the retail pharmacy business at or from the premises and of the date from which that condition, variation or revocation is to have effect.

• (4) The registrar may, with immediate effect—

• (a) impose a new condition in respect of premises already entered in Part 3 of the register; or

• (b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

if, in the registrar’s opinion, the giving of reasonable notice as required by subsection (3) would prejudice the health, safety or well-being of members of the public.

• (5) The registrar must give notice in writing of any decision under subsection (4) to the person carrying on a retail pharmacy business at or from the premises.

• (6) The notice under subsection (5) must be sent—

• (a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

• (b) where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

• (c) where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

• (7) Where premises are entered in the register because condition C in section 74B is met by virtue of subsection (4)(a)(ii) of that section, the registrar may, on making the entry of the premises in the register, also make that entry subject to a condition that the applicant for registration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is made.

74E

• (1) Where the entry of premises entered in Part 3 of the register is subject to conditions imposed under section 74D(1), the person carrying on the business at or from the premises may apply to the registrar for any of the conditions imposed to be varied or revoked.

• (2) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

• (3) Rules under subsection (2) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

• (b) about the information to be provided in respect of applications;

• (c) about the circumstances in which applications may be refused by the registrar;

• (d) about the giving of notice of the decision in respect of the application to the applicant by the registrar.

• (4) The registrar may vary a condition imposed under section 74D(7) by extending the period within which the applicant for registration must become a person lawfully conducting a retail pharmacy business.

• (5) Where premises are entered in the register subject to a condition imposed under subsection (7) of section 74D, the registrar may remove the entry if the applicant is not a person lawfully conducting a retail pharmacy business at or from the premises within the period determined by the registrar in accordance with that subsection or within such longer period as the registrar may, by virtue of subsection (4), allow.

• (6) Where the registrar—

• (a) varies a condition under subsection (5); or

• (b) removes an entry of premises in Part 3 of the register under subsection (4),

the registrar must send to the person who applied for registration a statement in writing giving that person notice of the decision and the reasons for it.

• (7) The notice under subsection (6) must be sent—

• (a) where the person who applied for registration is an individual, to that individual at that individual’s home address in the register;

• (b) where that person is a partnership, to that partnership at its principal office;

• (c) where that person is a body corporate, to that body corporate at its registered or principal office.

74F

• (1) Where, in pursuance of an application, the registrar enters premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the entry.

• (2) The written confirmation under subsection (1) must include—

• (a) the number of the entry;

• (b) the date on which the entry was made;

• (c) the period for which the entry is valid; and

• (d) details of any conditions to which the entry is subject by virtue of section 74D.

• (3) Where, in pursuance of an application, the registrar renews the entry of premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the renewal.

• (4) The written confirmation under subsection (3) must include—

• (a) the number of the entry;

• (b) the date on which the renewal of the entry was made;

• (c) the period for which the renewal of the entry is valid; and

• (d) details of any conditions to which the renewal of the entry is subject by virtue of section 74D.

• (5) Where the registrar refuses an application for the entry of premises in Part 3 of the register under section 74A, or for the renewal of an entry of premises in the register under that section, the registrar must give to the applicant written notice of that refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40 of the Pharmacy Order 2010.

• (6) Where, under section 74J, the registrar enters premises or a group of premises in Part 3 of the register, the registrar must give written confirmation of the entry to the person who will be carrying on a retail pharmacy business at or from the premises, or at or from each set of premises in the group of premises.

• (7) The written confirmation under subsection (6) must include—

• (a) the number of the entry;

• (b) the date on which the entry was made; and

• (c) details of any conditions to which the entry is subject by virtue of section 74J(4).

74G

• (1) An application may be made to the registrar by the person carrying on a retail pharmacy business at or from any premises entered in Part 3 of the register under section 74A or 74J for the premises to be removed from the register.

• (2) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

• (3) Rules under subsection (2) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

• (b) about the information to be provided by the applicant;

• (c) about the circumstances in which applications may be refused; and

• (d) for written notice of the outcome of the application to be given to the applicant by the registrar.

74H

• (1) Subject to subsection (2), where a change occurs in the ownership of a retail pharmacy business carried on at or from premises entered in Part 3 of the register under section 74A, the entry of the premises in the register ceases to be valid at the end of the relevant period unless the registrar is notified in writing of the change prior to the end of the relevant period by the person who, as a result of the change, will be the person carrying on the business at or from the premises.

• (2) Subsection (1) only applies if the relevant period is shorter than the period for which the entry would otherwise have remained valid under section 74A.

• (3) Where, before the end of the relevant period, the registrar is notified of a change in the ownership of a retail pharmacy business carried on at or from premises entered in Part 3 of the register, the registrar must, on receipt of a fee of the amount prescribed in rules under article 36(1)(c) of the Pharmacy Order 2010, amend the entry relating to the premises in Part 3 of the Register to record the name and address of the person who, as a result of the change, will be the person carrying on the retail pharmacy business at or from the premises.

• (4) For the purposes of subsections (1) to (3), the relevant period—

• (a) if the change occurs on the death of the person carrying on the business or, in the case of a partnership, on the death of one of the partners, means the period of three months beginning with the date of death; and

• (b) in any other case, means the period of 28 days beginning with the date on which the change occurred.

• (5) If the entry of premises entered in Part 3 of the register under section 74A ceases to be valid under this section, the premises are to be treated for all purposes as no longer being entered in the register and accordingly the registrar must remove the entry from the register.

• (6) The registrar must restore the entry of the premises to Part 3 of the register if—

• (a) an application for restoration is made to the registrar in accordance with section 74I(1) and with rules made under section 74I(3);

• (b) a fee of an amount prescribed in rules under article 36(1)(b) of the Pharmacy Order 2010 (fees in connection with entry) is paid; and

• (c) the registrar is satisfied that the standards that are provided for in rules made set under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at or from the premises.

• (7) Subject to subsection (8), an entry restored to the register under subsection (6)—

• (a) is still to be treated as having been entered in Part 3 of the register under section 74A;

• (b) is subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of subsection (5);

• (c) is valid for the same period as the period for which the entry would have been valid under section 74A had it not been removed from Part 3 of the register by virtue of subsection (5) of this section.

• (8) Where an entry of premises in Part 3 of the register is restored by the registrar under subsection (6) and the applicant is a person falling within section 74I(2)(b), the registrar may—

• (a) on restoring the entry of the premises to the register, make that entry subject to a condition that the applicant for restoration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is restored; and

• (b) subsequently remove the entry of the premises from Part 3 of the register if the applicant is not a person lawfully conducting a retail pharmacy business within the period determined by the registrar in accordance with paragraph (a).

• (9) Where under subsection (8)(b) the registrar removes an entry of premises from Part 3 of the register, the registrar must give to the person who was carrying on a retail pharmacy business at or from the premises immediately prior to the removal written notice of the removal and the reasons for it.

• (10) The notice under subsection (9) must be sent—

• (a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

• (b) where the retail pharmacy business is carried on by a partnership, to the principal office of that partnership;

• (c) where the retail pharmacy business is carried on by a body corporate, to the registered or principal office of that body corporate.

74I

• (1) An application may be made to the registrar for the entry of premises removed from Part 3 of the register by virtue of section 74H(5) to be restored to the register.

• (2) An application under subsection (1) must be made by the person who, in consequence of the change of ownership, has become the owner of the business and that person must be—

• (a) a person who is lawfully conducting a retail pharmacy business; or

• (b) a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at or from those premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

• (3) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

• (4) Rules under subsection (3) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

• (b) about the information to be provided in respect of applications;

• (c) about the circumstances in which an application for restoration under subsection (1) may be treated by the registrar as an application for the renewal of registration under section 74A(4) as well as an application for restoration.

• (5) Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under subsection (1), the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the restoration.

• (6) The notice given by the registrar under subsection (5) must specify—

• (a) the period for which the entry restored to Part 3 of the register is valid;

• (b) any conditions to which the entry of the premises restored to Part 3 of the register is subject.

• (7) Where the registrar refuses an application under this section for the restoration to Part 3 of the register of an entry relating to any premises, the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the decision and the reasons for it.

• (8) The notice under subsections (5) and (7) must be sent—

• (a) where the applicant is an individual, to that individual at that individual’s home address in the register;

• (b) where the applicant is a partnership, to the principal office of that partnership;

• (c) where the applicant is a body corporate, to the registered or principal office of that body corporate.

74J

• (1) This section applies in relation to premises in Great Britain.

• (2) If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may under this section enter in Part 3 of the register—

• (a) premises; or

• (b) premises comprising a specified group of premises,

with regard to the emergency.

• (3) The registrar may enter in Part 3 of the register by virtue of subsection (2)(b) all of the premises in a specified group of premises without first identifying each set of premises in the group.

• (4) The registrar may make the entry of premises entered in Part 3 of the register under this section subject to such conditions as the registrar considers necessary to impose for the purpose of securing the safe and effective practice of pharmacy in the course of the business carried on at or from those premises.

• (5) The power in subsection (4)—

• (a) may be exercised on the making of the entry or subsequently;

• (b) includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

• (6) The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group may be subject to the same conditions as the entry of the other premises in the group or it may be subject to different conditions.

• (7) The conditions to which the entry of premises entered in Part 3 of the register under this section is subject may include conditions relating to their physical state, safety and security and the conditions in which medicinal products (including controlled drugs) are stored at those premises.

• (8) The registrar may not under subsection (4)—

• (a) impose a new condition in respect of the entry of premises already entered in Part 3 of the register; or

• (b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on a retail pharmacy business at or from the premises and of the date from which that condition, variation or revocation is to have effect.

• (9) The entry of premises entered in Part 3 of the register under this section may be removed by the registrar, which—

• (a) the registrar must do if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (2) no longer exist;

• (b) the registrar may do for any other reason at any time including where the registrar has grounds for suspecting that there is a failure to comply with any conditions to which the entry of the premises in Part 3 of the register is subject.

• (10) The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group of premises may be removed without removing the entries of the other premises in the group, or it may be removed by virtue of a decision to remove the entries of all of the premises in the group.

• (11) In this section, and in section 74K, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004 (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.

74K

• (1) If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may annotate—

• (a) the entry of a registered pharmacy entered in Part 3 of the register under section 74J to designate that pharmacy as a pharmacy from which drugs, medicines and appliances may be ordered in a specified capacity; or

• (b) the entries of a specified group of registered pharmacies entered in Part 3 of the register under section 74J to designate that group as a group of pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

• (2) The registrar may make an annotation, by virtue of subsection (1), to the entry of a registered pharmacy entered in Part 3 of the register under section 74J in such a way as to distinguish that annotation from an annotation in respect of a registered pharmacy made otherwise than by virtue of subsection (1).

• (3) Annotations made by virtue of subsection (1)—

• (a) must be removed by the registrar if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (1) no longer exist;

• (b) may be removed by the registrar for any other reason at any time.

• (4) An annotation of the entry of a registered pharmacy made by virtue of subsection (1)(b) as one of a specified group may be removed without removing the annotations of the entries of the other registered pharmacies in the group, or it may be removed by virtue of a decision to remove the annotations of the entries of all the registered pharmacies in the group.

74L

A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in Great Britain were, or were not, entered in Part 3 of the register (whether under section 74A or section 74J) is admissible in any proceedings as evidence (or in Scotland, as sufficient evidence) that those premises were, or were not, entered in the register on that date.

84A

• (1) The General Pharmaceutical Council may make such provision as it considers appropriate in rules for any purpose for which rules are authorised or required to be made by it under Part 4 of this Act.

• (2) Article 66 of the Pharmacy Order 2010 (rules) applies to the making of rules by the General Pharmaceutical Council under any provision of Part 4 of this Act other than section 72A as it applies to the making of rules by the General Pharmaceutical Council under Part 3 of that Order (registered pharmacies: standards in retail pharmacies).

• (3) The power of the General Pharmaceutical Council to make rules under section 72A may be exercised so as to make different provision for different areas or in relation to different cases or different circumstances to which the power is applicable, and to make any such provision subject to such exceptions, limitations and conditions (if any) as the General Pharmaceutical Council considers necessary or expedient.

• (4) Before making rules under section 72A, the General Pharmaceutical Council must publish draft rules and invite representations to be made to it about the draft by—

• (a) the Secretary of State, the Scottish Ministers and the Welsh Ministers, and

• (b) any other persons appearing to it appropriate to consult about the draft.

• (5) No rules made under section 72A by the General Pharmaceutical Council are to come into force until approved by order of the Privy Council.

• (6) The power vested in the Privy Council to make an order under subsection (5) may be exercised by any two or more members of the Privy Council.

• (7) The making of an order under subsection (5) is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

• (8) Where an order under subsection (5) is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence and in Scotland sufficient evidence of—

• (a) the fact that the order was duly made, and

• (b) the order’s terms.

Exemption for re-exports.