Source: http://www.legislation.gov.uk/uksi/2010/1617/schedule/part/5/made
Timestamp: 2018-03-20 23:35:50
Document Index: 689254939

Matched Legal Cases: ['ART 5', 'art 3', 'art 3', 'art 3', 'art 4', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 4', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3', 'art 3']

PART 5Applications relating to Part 3 of the Register
Applications: general
21. The Council may make such provision as it considers appropriate for applications under this Part to be made on line to the Registrar.
Entry of premises in the Register
22.—(1) Subject to the following paragraphs, applicants for the entry of premises in Part 3 of the Register may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.
(2) An application under this rule must be made to the Registrar by the person who is, or intends to be, the person carrying on a retail pharmacy business at the premises to which the application relates.
(3) The application form must, in particular—
(a)require the applicant to specify—
(i)the applicant’s full name, address and contact details (including a telephone number and electronic mail address, where possible),
(ii)the full postal address of the premises to which the application relates,
(iii)whether the applicant is aware that the premises to which the application relates have previously been entered in Part 3 of the Register,
(iv)the name under which the retail pharmacy business that is, or is to be, carried on at the premises trades or is to trade,
(v)whether the applicant is, or will be, a person lawfully conducting a retail pharmacy business at the premises within the meaning of Part 4 of the Act,
(vi)the date, or intended date, of the commencement of the retail pharmacy business carried on, or to be carried on, at the premises,
(vii)where the retail pharmacy business is, or is to be, carried on at the premises by a representative, the name of the responsible pharmacist;
(viii)where the applicant is a partner in a partnership, the names of all the partners in the partnership,
(ix)where the applicant is a body corporate—
(aa)the names of all of the directors of the body corporate, and
(bb)the name of the superintendent pharmacist;
(b)include a demand that the applicant pay the prescribed fee in respect of the application;
(c)require the applicant to provide—
(i)a description of the premises to which the application relates,
(ii)details of the type of activities undertaken, or intended to be undertaken, at the premises,
(iii)a plan, drawn to scale, of the internal layout of the premises showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored,
(iv)a declaration—
(aa)confirming that the standards set in rules under article 7(1) of the Order in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business carried on, or intended to be carried on, at the premises, and
(bb)providing details of any relevant offence or relevant investigation within the meaning of article 7(6)(a) and (b) of the Order;
(d)provide any other necessary supporting documents, information or evidence as mentioned in the application form;
(e)inform the applicant that, if the declaration included in the application is not completed to the satisfaction of the Registrar, the Registrar may refuse to enter the premises in Part 3 of the Register because the conditions specified in section 74B of the Act are not met; and
(f)require the applicant to sign and date the application.
(4) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.
(5) For the purposes of paragraph (3)(a)(i), the address of the applicant is—
(a)where the retail pharmacy business is, or is to be, carried on at the premises by an individual, that individual’s home address in the Register;
(b)where the retail pharmacy business is, or is to be, carried on at the premises by a partnership, the address of the principal office of that partnership; or
(c)where the retail pharmacy business is, or is to be, carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.
(6) Where the premises to which the application relates have previously been entered in Part 3 of the Register, the Registrar may dispense with any of the requirements under this rule for the applicant to provide such documents, information or evidence in support of the application as the Registrar may determine in the circumstances of the applicant’s case.
(7) The Registrar must refuse any application for the entry of premises in Part 3 of the Register if—
(a)it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or
(b)the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.
Variation or revocation of conditions of entry of premises entered in the Register
23.—(1) Subject to the following paragraphs, applicants for variation or revocation of any of the conditions to which an entry of premises entered in Part 3 of the Register is subject may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.
(2) An application under this rule may be made to the Registrar by the person carrying on a retail pharmacy business at premises entered in Part 3 of the Register where the entry of the premises in the Register is subject to one or more conditions.
(ii)the full postal address of the premises at which the retail pharmacy business is carried on,
(iii)the number of the entry of the premises entered in the Register to which the application relates,
(iv)the name under which the retail pharmacy business carried on at the premises trades,
(v)where the retail pharmacy business is carried on at the premises by a representative, the name of the responsible pharmacist,
(vi)where the retail pharmacy business is carried on at the premises by a body corporate, the name of the superintendent pharmacist,
(vii)details of any improvement notices to which the person carrying on a retail pharmacy business at the premises is subject,
(viii)details of any conditions to which the entry of the premises entered in Part 3 of the Register is subject,
(ix)the condition (or conditions) imposed on the entry of the premises entered in Part 3 of the Register to which the application relates,
(x)whether the application is an application for variation or revocation of such a condition (or such conditions),
(xi)the grounds on which the application is made including any reasons why the applicant considers that the relevant condition (or conditions) cannot be complied with,
(xii)if the application is an application to vary a condition (or conditions), the terms of the variation that is being sought; and
(b)require the applicant to—
(i)provide any other necessary supporting documents, information or evidence as mentioned in the application form, and
(ii)sign and date the application.
(a)where the retail pharmacy business is carried on at the premises by an individual, that individual’s home address in the Register;
(b)where the retail pharmacy business is carried on at the premises by a partnership, the address of the principal office of that partnership; or
(c)where the retail pharmacy business is carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.
(6) The Registrar must refuse any application under this rule—
(a)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or
(b)if the Registrar considers that——
(i)to vary or revoke the condition (or conditions) to which the application relates would prejudice the health, safety or well-being of members of the public, or
(ii)it is necessary to retain the relevant condition (or conditions) in order to ensure the safe and effective practice of pharmacy at the premises.
(7) If the Registrar grants an application under this rule—
(a)the Registrar must ensure that an appropriate alteration to the Register is made to record any variation or revocation of a condition (or conditions) to which the entry of the premises entered in Part 3 of the Register is subject; and
(b)the Registrar may charge a fee, of such amount as may reasonably be determined by the Registrar in the circumstances of the application, in connection with the cost of making an appropriate alteration to the Register.
Renewal of an entry of premises entered in the Register
24.—(1) Subject to the following paragraphs, applicants for the renewal of an entry of premises entered in Part 3 of the Register may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.
(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises at least two months before the date on which the entry of the premises entered in Part 3 of the Register would cease to be valid if not renewed.
(3) The Registrar must send to each person carrying on a retail pharmacy business at premises which are entered in Part 3 of the Register the relevant application form for the renewal of the entry relating to the premises at least three months before the date on which the entry of the premises entered in that part of the Register would cease to be valid if not renewed.
(4) The application form must, in particular—
(v)whether the applicant is a person lawfully conducting a retail pharmacy business at the premises within the meaning of Part 4 of the Act,
(vi)the date of the commencement of the retail pharmacy business carried on at the premises,
(vii)where the applicant is a partner in a partnership, the names of all the partners in the partnership,
(viii)where the applicant is a body corporate—
(bb)the name of the superintendent pharmacist, and
(ix)where the retail pharmacy business is carried on at the premises by a representative, the name of the responsible pharmacist, and
(ii)details of any conditions to which the entry of the premises entered in Part 3 of the Register is subject,
(iii)details of any improvement notices to which the person carrying on a retail pharmacy business at the premises is subject,
(iv)details of the type of activities undertaken at the premises, and
(v)a declaration—
(aa)confirming that the standards set in rules under article 7(1) of the Order in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business carried on at the premises, and
(d)inform the applicant that if the declaration included in the application is not completed to the satisfaction of the Registrar, the Registrar may refuse to renew the entry of the premises in Part 3 of the Register; and
(e)require the applicant to sign and date the application.
(5) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.
(6) For the purposes of paragraph (4)(a)(i), the address of the applicant is—
(7) The Registrar must not renew an entry of premises entered in Part 3 of the Register—
(a)if the application is not received by the Registrar within the time limit specified in paragraph (2);
(b)if the application is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or
(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.
(8) The Registrar may only renew the entry of premises entered in Part 3 of the Register for a period exceeding one year beginning with the date on which that entry would otherwise have ceased to be valid—
(a)if the entry of the premises in Part 3 of the Register is not subject to any conditions imposed by virtue of section 74D of the Act;
(b)if the person carrying on a retail pharmacy business at the premises is not subject to the terms of an improvement notice served under article 13 of the Order; and
(c)if the period for which the entry is renewed does not exceed 36 months from the date on which the entry would otherwise have ceased to be valid if not renewed.
(9) For the purposes of section 74A(7) of the Act, the prescribed circumstances are that—
(a)the Registrar has received an application under this rule for the renewal of an entry of premises entered in Part 3 of the Register before the end of the period specified in paragraph (2); and
(b)the Registrar has not determined the application before the date on which the entry in Part 3 of the Register to which the application relates would cease to be valid if not renewed.
Annotations made to an entry of premises entered in the Register
25.—(1) Subject to the following paragraphs, applicants may apply to the Registrar for an annotation in respect of a specialisation to be made to an entry of premises entered in Part 3 of the Register using the relevant application form which must be in such form as the Council may from time to time determine.
(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises to which the application relates.
(iii)the number of the entry of the premises entered in the Register to which the application relates, and
(iv)the name under which the retail pharmacy business carried on at the premises trades;
(b)include a demand that the applicant pay the prescribed fee in respect of the application; and
(c)require the applicant to—
(i)specify the type of specialisation which is to be the subject matter of the annotation,
(ii)declare the applicant’s intention to adhere (or to continue to adhere) to the standards set by the Council in rules under article 7(1) of the Order relating to the safe and effective practice of pharmacy at registered pharmacies,
(iii)provide any other necessary supporting documents, information and evidence as mentioned in the application form, and
(iv)sign and date the application.
(6) Where the Registrar grants an application under this rule, the Registrar must ensure that an appropriate annotation is made to the entry of the premises entered in Part 3 of the Register to denote the type of specialisation that relates to the retail pharmacy business carried on at the premises.
(7) The Registrar must refuse any application made under this rule—
(b)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application.
Renewal of an annotation made to an entry of premises entered in the Register
26.—(1) Subject to the following paragraphs, applicants for the renewal of an annotation in respect of a specialisation made to an entry of premises entered in Part 3 of the Register may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.
(2) An application under this rule must be made to the Registrar by the person carrying on a retail pharmacy business at the premises to which the application relates at least two months before the date on which the entry of the premises in Part 3 of the Register would cease to be valid if not renewed.
(3) The Registrar must send an application form to each person carrying on a retail pharmacy business at premises entered in Part 3 of the Register, where the entry of the premises entered in that part of the Register is subject to an annotation to denote a specialisation, at least three months before the date on which that entry would cease to be valid if not renewed.
(4) If a person carrying on a retail pharmacy business at premises entered in Part 3 of the Register, where the entry of the premises entered in that part of the Register is subject to an annotation to denote a specialisation, has not received an application form for the renewal of that annotation at least three months before the date on which that entry would cease to be valid if not renewed, that person must notify the Registrar accordingly.
(5) The application form must, in particular—
(i)the applicant’s name, address and contact details (including a telephone number and electronic mail address, where possible),
(v)the annotation, or annotations, to which the application relates;
(6) The applicant must also provide such additional documents, information or evidence as the Registrar may reasonably require for the purposes of verifying the information in, or determining, the application.
(7) For the purposes of paragraph (5)(a)(i), the address of the applicant is—
(8) The Registrar must refuse any application under this rule—
(a)if it is not received by the Registrar within the time limit specified in paragraph (2);
(b)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar; or
Voluntary removal of an entry of premises or an annotation from the Register
27.—(1) Subject to the following paragraphs, applicants for the voluntary removal of an entry of premises entered in Part 3 of the Register from that part of the Register, or for the removal of an annotation in respect of a specialisation made to such an entry, may apply to the Registrar using the relevant application form which must be in such form as the Council may from time to time determine.
(iii)whether the application is for the removal of an entry of premises entered in Part 3 of the Register from that part of the Register or for the removal of an annotation in respect of a specialisation made to such an entry,
(iv)the number of the entry of the premises entered in the Register to which the application relates,
(v)the name under which the retail pharmacy business carried on at the premises trades,
(vi)where the retail pharmacy business is carried on at the premises by a representative, the name of the responsible pharmacist,
(i)state the reason for the application,
(ii)declare that the applicant is not aware of any investigation by any enforcement or regulatory body, or proceedings brought by such a body, that relate to the premises,
(iii)provide any necessary supporting documents, information or evidence as mentioned in the application form, and
(6) Where the Registrar grants an application under this rule, the Registrar must ensure that an appropriate alteration is made to Part 3 of the Register removing the entry or, as the case may be, the annotation in respect of a specialisation made to the entry, from that part of the Register.
Restoration of an entry of premises entered in the Register: general
28.—(1) Subject to the following paragraphs, applicants for the restoration of an entry of premises entered in Part 3 of the Register that has been removed from that part of the Register—
(a)under article 14(4)(a) of the Order;
(b)under section 74A(7) of the Act (registration of premises: Great Britain); or
(c)by virtue of an application under section 74G of the Act (voluntary removal from the register: Great Britain);
may apply to the Registrar to have the entry restored to Part 3 of the Register using the relevant application form which must be in such form as the Council may from time to time determine.
(2) Applications under this rule must be made to the Registrar by the person who, immediately before the removal, was the person carrying on a retail pharmacy business at the premises no later than twelve months from the date on which the entry was removed from Part 3 of the Register.
(ii)the full postal address of the premises at which the retail pharmacy business is to be carried on,
(iv)the name under which the retail pharmacy business that is to be carried on at the premises trades,
(v)where the retail pharmacy business is to be carried on at the premises by a representative, the name of the responsible pharmacist,
(vi)where the applicant is a partner in a partnership, the names of all the partners in the partnership,
(vii)where the applicant is a body corporate—
(viii)the intended date of commencement of the retail pharmacy business that is to be carried on at the premises;
(i)details of any conditions to which the entry of the premises entered in Part 3 of the Register was subject immediately prior to its removal from that part of the Register,
(ii)details of any improvement notices to which the person carrying on the retail pharmacy business at the premises was subject immediately prior to the removal of the entry of the premises from Part 3 of the Register,
(iii)details of the type of activities to be undertaken at the premises,
(iv)a plan, drawn to scale, of the internal layout of the premises showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored, and
(aa)confirming that the standards set in rules under article 7(1) of the Order in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business that is to be carried on at the premises, and
(bb)providing details of any relevant offence or relevant investigation within the meaning of article 7(6)(a) and (b) of the Order; and
(d)require the applicant to—
(i)declare whether there has been a change in the name under which the retail pharmacy business that is to be carried on at the premises trades,
(ii)provide any necessary supporting documents, information or evidence as mentioned in the application form, and
(iii)sign and date the application.
(a)where the retail pharmacy business is to be carried on at the premises by an individual, that individual’s home address in the Register;
(b)where the retail pharmacy business is to be carried on at the premises by a partnership, the address of the principal office of that partnership; or
(c)where the retail pharmacy business is to be carried on at the premises by a body corporate, the address of the registered or principal office of that body corporate.
(6) The Registrar must refuse the application under this rule—
(b)if it is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar;
(c)if the applicant has not paid, or has not made arrangements with the Registrar to pay by direct debit, the prescribed fee in respect of the application; or
(d)if the Registrar considers that restoring the entry of the premises to Part 3 of the Register would prejudice the health, safety or well-being of members of the public.
Restoration of an entry of premises in the Register: change of ownership
29.—(1) Subject to the following paragraphs, applicants for the restoration of an entry of premises entered in Part 3 of the Register to that part of the Register may, where the entry has been removed from the Register under section 74H of the Act (change of ownership of retail pharmacy business: Great Britain), apply to the Registrar to have the entry restored to Part 3 of the Register using the relevant application form which must be in such form as the Council may from time to time determine.
(2) Applications under this rule must be made to the Registrar by the person who is to be a person carrying on a retail pharmacy business at the premises before the end of the period of twelve months beginning with the date on which the entry was removed from Part 3 of the Register.
(iv)the name under which the retail pharmacy business carried on at the premises is to trade,
(v)the intended date of commencement of the retail pharmacy business to be carried on at the premises,
(viii)where the retail pharmacy business is to be carried on at the premises by a representative, the name of the responsible pharmacist;
(ii)details of any conditions to which the entry of the premises in Part 3 of the Register was subject immediately prior to its removal from that part of the Register,
(iii)details of any improvement notices to which the person carrying on a retail pharmacy business at the premises was subject immediately prior to the removal of the entry of the premises from Part 3 of the Register,
(iv)details of the type of activities to be undertaken at the premises,
(v)a plan, drawn to scale, of the internal layout of the premises showing the areas in which medicinal products are intended to be sold or supplied, assembled, prepared, dispensed or stored, and
(vi)a declaration—
(aa)confirming that the standards set by the Council in rules under article 7(1) of the Order that are to be met in connection with the carrying on of a retail pharmacy business at a registered pharmacy are met in connection with the retail pharmacy business to be carried on at the premises, and
(d)require the applicant to sign and date the application.
(6) The Registrar may treat an application for restoration made under this rule as an application for the renewal of an entry of premises entered in Part 3 of the Register made under rule 24 as well as an application for restoration made under this rule if there is insufficient time available for the Registrar to process the application for restoration before the date on which the entry, if restored, would cease to be valid if not renewed.
(7) The Registrar must refuse the application under this rule—
Restoration of annotations made to an entry of premises in the Register
30.—(1) Paragraph (2) applies—
(a)where an entry of premises entered in Part 3 of the Register has been removed from that part of the Register under —
(i)article 14(4)(a) of the Order,
(ii)under section 74A(7) of the Act (registration of premises: Great Britain),
(iii)by virtue of an application under section 74G of the Act (voluntary removal from the register: Great Britain), or
(iv)under section 74H(5) of the Act (change of ownership of retail pharmacy business: Great Britain),
and an application has been made to the Registrar under rule 28 or rule 29 for the restoration of that entry to Part 3 of the Register; or
(b)where an annotation in respect of a specialisation made to an entry of premises entered in Part 3 of the Register has been removed from that part of the Register by virtue of an application under rule 27 of these Rules.
(2) Where paragraph (1) applies, applicants may apply to the Registrar to have an annotation in respect of a specialisation made to an entry of premises entered in Part 3 of the Register restored to that part of Register using the relevant application form which must be in such form as the Council may from time to time determine.
(3) An application under this rule must be made to the Registrar before the end of the period of twelve months beginning with the date on which the annotation was removed from the Register.
(ii)the full postal address of the premises at which the retail pharmacy business is, or is to be, carried on,
(iv)the name under which the retail pharmacy business carried on, or to be carried on, at the premises trades;
(7) The Registrar may refuse any application under this rule which is not accompanied by the necessary supporting documents, information or evidence as mentioned in the application form or subsequently required by the Registrar.
(8) The Registrar must refuse the application—
(a)if the application is not received by the Registrar within the time limit specified in paragraph (3);
(b)if the annotation made to an entry of premises entered in Part 3 of the Register was removed from that part of the Register because of a failure to provide any document, evidence or information and the relevant document, information or evidence is not included in the application; or