First Previous (PART 3 The Council of the Society ) Next (PART 5 Offences )

20 2007

Pharmacy Act 2007

PART 4

Pharmaceutical Registration System

Registers.

13 .— (1) The Council shall perform the function referred to in section 7 (2)(a)(i) by—

(a) setting up, as soon as practicable after the establishment of the Society, a register for each of the following:

(i) pharmacists;

(ii) druggists;

(iii) pharmaceutical assistants;

(iv) retail pharmacy businesses,

(b) entering in each of the registers mentioned in subparagraphs (i) to (iii) of paragraph (a) (the “personal registers”) the name of and other prescribed information concerning every person entitled to be registered there,

(c) entering in the retail pharmacy businesses’ register—

(i) the address of the premises in which the business is being or is to be carried on,

(ii) the name under which it is being or is to be carried on,

(iii) the name of the pharmacy owner, and

(iv) where the pharmacy owner is a corporate body, the name of the pharmacist specified under section 28 (a),

(d) otherwise maintaining the registers,

(e) ensuring that the information in the registers is available, without charge, to the public at all reasonable times.

(2) Without prejudice to the generality of subsection (1)(e), the Council shall publish each register by means of—

(a) the Internet, and

(b) at least one other method of publication,

within 12 months of the setting up of the register and thereafter at intervals of not more than 12 months.

(3) The duties imposed by subsections (1)(e) and (2) do not extend to the home addresses, telephone numbers and e-mail addresses of individuals and to such other similar information about them as the Council considers should, in the interests of the security and privacy of those individuals, not be disclosed.

Procedure and criteria for registration of pharmacists.

14 .— (1) The Council shall register a person in the pharmacists’ register if the person—

(a) makes an application which complies with the prescribed requirements in relation to such an application,

(b) complies with any requirement which may be imposed by the Council—

(i) to verify anything contained in the application,

(ii) to supply further information in relation to the application,

(iii) to make a statutory declaration supplying that information,

(c) pays the prescribed fee to the Council,

(d) satisfies the Council that the person is fit to be a registered pharmacist,

(e) holds a qualification appropriate for practice in accordance with section 16 ,

(f) is not an undischarged bankrupt,

(g) not being a national of the State or another Member State, satisfies the Council that he or she has the linguistic competence necessary to be a registered pharmacist in the State,

(h) being a national of the State or another Member State and lacking that competence, undertakes to acquire it.

(2) In determining whether a person is fit to be a registered pharmacist, the Council shall have regard to whether the person has—

(a) under the law of another state, been—

(i) prohibited from carrying on any activity in that state corresponding to the practice of a pharmacist or the carrying on of a retail pharmacy business, or

(ii) convicted in that state of an offence the nature of which has, in the opinion of the Council, a bearing on the person’s fitness to practise,

(b) under the law of the State or another state, been prohibited from carrying on any other practice, profession or occupation appearing to the Council to consist or mainly to consist of the provision of health care or services or social care or services.

(3) In registering a person who gives an undertaking under subsection (1)(h), the Council may impose a condition that the person acquires the linguistic competence referred to in that provision before practising in a way which entails dealing directly with the public.

(4) In registering a person whose qualification for practice is one to which section 16 (2)(b) applies, the Council may impose a condition that the person’s practice must be supervised by a registered pharmacist specified in the condition for such period as is so specified.

(5) Subsections (1) to (4) apply also in respect of the continued registration of a person in a personal register.

(6) This section does not apply in respect of the first registration of a person to whom section 15 (1) applies.

(7) Subsection (1)(d) to (g) does not apply in respect of the first registration of a person who—

(a) at any time during the period of 6 months immediately before the dissolution of the old Society (in this section referred to as the “dissolution”), became entitled to be registered as mentioned in an enactment referred to in section 15 (1)(a) and, immediately before dissolution, was still so entitled but was never so registered, or

(b) was, immediately before dissolution, a licentiate of Apothecaries Hall to whom a certificate under the Apothecaries Hall Act 1791 to transact the business of an apothecary was granted before 31 December 1975.

(8) In this section, “ another state ” means a state other than the State.

Registration of persons registered or entitled to be registered under repealed legislation.

15 .— (1) Subsections (2) and (3) make provision as respects a person who—

(a) immediately before the dissolution of the old Society (in this section referred to as the “dissolution”) was registered—

(i) as a pharmaceutical chemist under the Pharmacy Act (Ireland) 1875 or as a dispensing chemist and druggist under the Pharmacy Act 1951 ,

(ii) as a druggist under the Pharmacy Act, (Ireland) Amendment Act 1890,

(b) before dissolution, was a pharmaceutical assistant.

(2) As soon as practicable after dissolution the Council shall—

(a) in the case of a person to whom subsection (1)(a)(i) applies, register the person in the pharmacists’ register,

(b) in the case of a person to whom subsection (1)(a)(ii) applies, register the person in the druggists’ register,

(c) in the case of a person to whom subsection (1)(b) applies, register the person in the pharmaceutical assistants’ register.

(3) A person who is to be registered under subsection (2) shall be regarded, for all purposes except those of that subsection, as having been so registered immediately upon dissolution.

Qualifications for practice.

16 .— (1) A person holds a qualification appropriate for practice if he or she has received in the State the prescribed training and education and has the prescribed qualifications.

(2) A person applying for registration in the pharmacists’ register who does not hold a qualification appropriate for practice as a pharmacist by virtue of subsection (1) shall be regarded as having a qualification appropriate for practice if—

(a) he or she is a national of a relevant state and satisfies the Council as to one of the requirements set out in subsections(3) to (5), or

(b) he or she has, in a third country received such training and education, passed such examinations and obtained such qualifications as are, in the opinion of the Council, of a standard not lower than the standard of those necessary for practice in the State.

(3) The first of the requirements referred to in subsection (2)(a) is that the person holds a diploma, certificate or other evidence of formal qualification in pharmacy awarded after training in accordance with Article 44 of the Professional Qualifications Directive and referred to in Annex V, point 5.6.2 to that Directive.

(4) The second of those requirements is that the person holds evidence of the formal qualifications as a pharmacist referred to in Article 23 of the Professional Qualifications Directive and is a person in respect of whom a certificate has been issued by a competent authority stating that he or she has been effectively and lawfully engaged in the activities of a pharmacist for at least 3 consecutive years during the 5 years before the issue of the certificate.

(5) The third of those requirements is that the person—

(a) holds a diploma, certificate or other evidence of formal qualification as a pharmacist granted by a competent authority of a third country, and the diploma, certificate or other evidence has been recognised by a relevant state for the purpose of being a pharmacist in that state, and

(b) has experience, of at least three years, of practising as a pharmacist in that state certified in accordance with Article 3.3 of the Professional Qualifications Directive.

(6) The Council may—

(a) so as to inform itself for the purposes of subsection (2)(b) about the standard of training, education, examinations and qualifications in another state, require a person to whom that provision appears to apply to sit an examination,

(b) in any case in which it is in any doubt about a matter referred to in that provision, require a person to whom that provision appears to apply to undergo such training as it may specify.

(7) Schedule 2 makes further provision as to the recognition of professional qualifications in pharmacy.

(8) In this section—

“competent authority” means, in relation to a relevant state, the authority designated in accordance with Article 56.3 of the Professional Qualifications Directive;

“Professional Qualifications Directive” means Directive 2005/36/EC of 7 September 2005 on the recognition of professional qualifications as amended by Council Directive 2006/100/EC of 20 November 2006 adapting certain Directives in the field of freedom of movement of persons by reason of the accession of Bulgaria and Romania;

“relevant state” means—

(a) a Member State (other than the State),

(b) a state that is a contracting state to the EEA Agreement within the meaning given by the European Communities (Amendment) Act 1993 (other than a Member State or the State),

(c) the Swiss Confederation;

“third country” means a country that is not a relevant state or the State.

(9) An expression used in this section and also in the Professional Qualifications Directive has the same meaning in this section as it has in that Directive.

Procedure and criteria for registration of retail pharmacy businesses.

17 .— (1) The Council shall register a retail pharmacy business in the retail pharmacy businesses’ register if the applicant for registration—

(a) is the pharmacy owner,

(b) specifies in the application the address of the premises in which the business is being or is to be carried on and the name under which it is being or is to be carried on and otherwise meets the prescribed requirements for the application,

(c) specifies in the application the name of the registered pharmacist who is or is to be in whole-time charge of the carrying on of the business there,

(d) complies with any requirement of the Council to—

(i) verify anything contained in the application,

(ii) supply further information in relation to the application,

(iii) make a statutory declaration supplying that information,

(e) pays the prescribed fee to the Council,

(f) satisfies the Council that the retail pharmacy business will be conducted in accordance with regulations under section 18 .

(2) Where a pharmacy owner carries on business as such in two or more premises, each of those premises shall, for the purposes of subsection (1), be regarded as separate premises in which a retail pharmacy business is being or is to be carried on.

(3) Subsections (1) and (2) apply also in respect of the continued registration of a retail pharmacy business.

(4) A change in the ownership of a retail pharmacy business shall have the effect of cancelling its registration.

(5) The cancellation of the registration of a retail pharmacy business under subsection (4) shall take effect—

(a) in the case of a change in ownership brought about by the death of an owner or joint owner, at the end of the period of three months beginning with the date of the death, and

(b) in any other case, at the end of the period of 28 days beginning with the date of the change in ownership.

(6) In subsection (4), a “ change in the ownership of a pharmacy ”—

(a) in the case of a pharmacy which is owned by two or more persons, includes a change of one of the co-owners,

(b) in the case of a pharmacy which is not so owned, includes a change which results in its being so owned, and

(c) in the case of a pharmacy which is owned by a company, includes the acquisition or disposal in one transaction or in a series of transactions of shares amounting in value to more than half of those issued by the company.

Regulation of retail pharmacy businesses.

18 .— (1) The Minister may, for the purposes of the health, safety and convenience of the public, make regulations about all or any of the following matters in respect of retail pharmacy businesses:

(a) the manner in which medicinal products are prepared there;

(b) the supervision of those processes there;

(c) the physical characteristics of that part of the premises which is to be provided for the conduct of those processes, including the separation of that part from the rest of the premises;

(d) the facilities to be provided for the conduct of those processes;

(e) the physical characteristics of the part of the premises which is to be used for the storage of medicinal products;

(f) the conditions, (including those relating to temperature, humidity, cleanliness and sanitation) in which medicinal products are prepared, stored, sold, supplied and dispensed there;

(g) the precautions to be taken before medicinal products are sold or supplied there;

(h) the disposal of medicinal products;

(i) the manner in which medicinal products are to be sold or supplied there;

(j) the physical characteristics of that part of the premises which is to be provided for members of the public being sold or supplied with medicinal products or to whom medical prescriptions are being dispensed, and the facilities within that part;

(k) the facilities to be provided and arrangements made there to enable the review, if necessary in private, of the medicinal treatment of a person to whom medicinal products are being or might be sold or supplied and the counselling, if necessary in private, of that person in connection with that treatment;

(l) the keeping of records of and in connection with the sale and supply of medicinal products and the dispensing of medical prescriptions;

(m) the retention, custody, transfer and disposal of those records following the cessation or transfer of the retail pharmacy business;

(n) the use and condition of any apparatus, equipment, utensil or furnishing used for or in connection with the carrying on of the retail pharmacy business;

(o) the safe keeping of medicinal products there.

(2) In subsection (1), “medicinal product” includes veterinary medicinal products within the meaning of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004.

(3) A person who contravenes a relevant provision shall be guilty of an offence.

(4) In subsection (3), a “ relevant provision” is any provision of regulations made under this section designated as such in the regulations.

Inspection of premises of retail pharmacy business for the purposes of section 18 .

19 .— (1) In any case where the Council considers that it is appropriate, it may cause an authorised officer to inspect the premises of a retail pharmacy business in respect of which an application for registration or continued registration has been made to ascertain if they comply with any regulations made by the Minister under section 18 .

(2) An authorised officer shall, as soon as practicable after the inspection furnish a written report to the Council, and a copy of the written report to the applicant.

Certificate of registration.

20 .— (1) As soon as practicable, the Council shall issue a certificate of registration to—

(a) a pharmacist who has, or

(b) a pharmacy owner whose retail pharmacy business has,

been registered or restored to a register.

(2) On continuing the registration of a registered pharmacist or registered retail pharmacy business, the Council shall issue a certificate of continued registration to the registered pharmacist or as the case may be the owner of the registered retail pharmacy business.

(3) A certificate of registration is current for the period of 12 months from the date of registration or restoration.

(4) A certificate of continued registration is current for the period of 12 months beginning with the day following the date of expiry of the immediately preceding certificate.

(5) A person who gives to another person a certificate issued to him or her under this section, with the intention that it be used to induce a third person to accept it as relating to that other person or who, with that intention, permits that other person to use the certificate, commits an offence.

(6) A person to whom a certificate has been issued under this section and who ceases to be registered within the currency of the certificate shall return it to the registrar within 14 days of the cessation.

Refusal to register: notification and appeal.

21 .— (1) If the Council refuses an application for registration, it shall notify the applicant in writing of its decision, the reason for it and the date when it was made.

(2) An applicant whose application for registration under this Act is refused by the Council, may appeal to the High Court against the refusal within a period of 3 months beginning on the date of receipt of notification under subsection (1).

(3) On an appeal under this section, the High Court may make—

(a) an order affirming the refusal,

(b) an order setting it aside and requiring the Council to proceed with the registration,

(c) an order (with or without directions) remitting the application to the Council for reconsideration and the making of a new decision, or

(d) any other order that it considers appropriate.

Maintenance and correction of registers.

22 .— (1) It is the duty of the Council to ensure that the registers are accurate.

(2) Without prejudice to the generality of subsection (1) the Council shall—

(a) make any alteration requiring to be made in the information contained in an entry,

(b) correct typographical and similar errors.

(3) The Council shall, as soon as practicable after doing anything under subsections (1) and (2), give notice in writing of that fact to the person to whom the cancellation, correction or other change relates or, as the case may be, that person’s next of kin.

(4) A person to whom an entry in a register relates shall notify the Council in writing of—

(a) any error that the person knows of in that entry, or

(b) any change of circumstances that is likely to have a bearing on the accuracy of the entry,

as soon as may be after the person becomes aware of that error or change in circumstances.

Evidence as to the registers.

23 .— In any legal proceedings—

(a) a document signed by the registrar stating—

(i) what is or is not registered,

(ii) what was or was not registered and when,

is, in the absence of evidence to the contrary, proof of the matters stated,

(b) a printed document—

(i) appearing to be a copy of any part of or an extract from a register, and

(ii) bearing a signed statement by the registrar that it is such a copy or extract,

is, in the absence of evidence to the contrary, proof of the content of so much of the register that is copied or extracted,

(c) a signature appearing to be the registrar’s on any such document is, in the absence of evidence to the contrary, to be taken as being the registrar’s.

Roll of pharmacy students.

24 .— (1) The Council may set up and maintain a roll of persons who are studying pharmacy in the schools of pharmacy of third level educational establishments in the State (but the fact that a person studying pharmacy there is not or has not been enrolled, shall have no effect on his or her eligibility to be awarded a qualification or to be registered).

(2) No fee shall be payable in respect of any enrolment under subsection (1).