8.—(1) The Pharmacy Act is amended in accordance with this regulation.
(2) In section 2 (the registers and registration), after subsection (2), insert—
“(2A) If a person who applies to have his name registered is a national of an EEA State exercising an enforceable Community right or a person of the description mentioned in section 4A(1A) of this Act, the registrar shall, within the specified period, give the applicant notice—
(a)of his decision on the application; and
(b)if he is not satisfied as mentioned in subsection (2)(a) of this section of the reasons for his decision and of the applicant’s right to appeal to the Council against the decision.
(2B) Failure to give the notice required by subsection (2A) of this section, within the specified period shall be treated as a decision against which an applicant may appeal to the Council.
(2C) In subsections (2A) and (2B), “the specified period” means—
(a)the period of three months beginning with the date on which the registrar receives the application with full supporting documentation; or
(b)such longer period as is permitted by Article 12 of the Pharmacists Recognition Directive.”.
(3) In section 4 (qualification by degree, diploma, etc. for registration)—
(a)in subsection (1), for “Byelaws”, substitute “Subject to subsection (4) below, byelaws”;
(b)in subsection (3), for “a diploma by which a person is qualified by virtue of section 4A(2)(a)”, substitute “an appropriate European diploma by which a person is qualified by virtue of section 4A”;
(c)after subsection (3), add—
“(4) Byelaws under subsection (1) above shall provide that in relation to a national of an EEA State exercising an enforceable Community right, or a person of the description mentioned in section 4A(1A), who—
(a)holds or has held a diploma granted in respect of pharmacy in any place outside the United Kingdom (other than an appropriate European diploma); or
(b)has passed the examinations necessary for obtaining such a diploma,
the registrar, or on appeal the Council, shall take the matters mentioned in subsection (5) below into account when deciding whether he is qualified to have his name registered under subsection (1) above.
(5) The matters are—
(a)if the diploma, or the passing of the examinations necessary for obtaining it, has been accepted by another EEA State as qualifying him to practise pharmacy in that State, that fact; and
(b)all his qualifications, or knowledge or experience, in pharmacy, wherever acquired, which are relevant to the question of whether his name should be registered.”.
(4) In section 4A (qualification by appropriate European diploma for registration)—
(a)for “a member State” in each place it occurs, substitute “an EEA State”;
(b)in the expression “the member State”, “any member State” or “that member State” in each place it occurs, for “member State”, substitute “EEA State”;
(c)in subsection (2)—
(i)for “(5)”, substitute “(4)”; and
(ii)after paragraph (c), add—
“(d)any diploma in pharmacy granted in an EEA State which is not specified in Schedule 1A to this Act and which does not fall within paragraph (b) or (c) above.”;
(d)in subsection (3), in paragraph (a), after “Act” insert “(except one falling within subsection (3C) of this section)”;
(e)after subsection (3A), insert—
“(3B) A diploma such as is mentioned in subsection (2)(d) of this section is not an appropriate European diploma for the purposes of this section unless the competent authorities of the EEA State in which it was awarded have certified—
(a)that the diploma is evidence of training which satisfies the requirements of Article 2 of the Pharmacists Training Directive; and
(b)that it is treated by the competent authorities of the EEA State in which it was awarded as equivalent to a diploma specified in respect of that State in Schedule 1A to this Act.
(3C) A diploma specified in Schedule 1A to this Act in respect of Italy which is not evidence of training which satisfies the requirements of the Pharmacists Training Directive and which was awarded in respect of training which began before 1st November 1993 (but not before 1st October 1987) and finished before 1st November 2003 is not an appropriate European diploma for the purposes of this section unless the competent authorities of Italy have certified—
(a)that the holder of the diploma has been effectively and lawfully engaged in Italy in one of the activities referred to in Article 1(2) of the Pharmacists Training Directive;
(b)that he was so engaged for at least three consecutive years during the five years preceding the date of the certificate; and
(c)that the activity in question was at all relevant times regulated in Italy.”;
(f)in subsection (4)—
(i)after “conditions specified in subsection (3)”, insert “, (3A), (3B) or (3C)”;
(ii)for paragraph (b), substitute—
“(b)the satisfaction of the condition specified in—
(i)paragraph (a)(ii) or (b)(ii) of subsection (3);
(ii)paragraph (b) of subsection (3A);
(iii)paragraph (a) or (b) of subsection (3B); or
(iv)paragraph (a), (b) or (c) of subsection (3C),
shall be established by the production of the relevant certificate, and not otherwise.”;
(g)omit subsection (5);
(h)in subsection (6)—
(i)for the definition of “competent authorities”, substitute—
““competent authorities”, in relation to an EEA State, means any authority or body designated by that EEA State in accordance with the Pharmacists Recognition Directive;”,
(ii)omit the definitions of “national” and “the period of the Greek derogation”, and
(iii)in the definition of “the Pharmacists Training Directive”, after “pharmacy”, add “as amended by Directive 2001/19/EC”.
(5) After section 4A, insert—
4B.—(1) A national of an EEA State who is exercising an enforceable Community right, or a person of the description mentioned in section 4A(1A), whose appeal under section 2(2) or (2B) is dismissed by the Council may appeal to the relevant court.
(2) In this section, the “relevant court” is—
(a)a county court; or
(b)in the case of a person whose address in the register, if he were registered, would be in Scotland, the sheriff in whose sheriffdom the address is situated.
(3) On an appeal under subsection (1) above, the relevant court may—
(a)dismiss the appeal;
(b)allow the appeal and quash the decision appealed against; or
(c)remit the case to the Council to dispose of the case in accordance with the court’s directions,
and may make such order as to costs (or, in Scotland, expenses) as it thinks fit.”.
(6) In section 8 (control of registrations by Statutory Committee), in subsection (1B), in paragraph (a), for “a member State”, substitute “an EEA State”.
(7) In section 24 (interpretation), in subsection (1) insert each of the following definitions at the appropriate place—
““EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993 and as amended by Decision of the EEA Joint Committee No. 84/2002 of 25th June 2002;”;
““EEA State” means a Contracting Party to the EEA Agreement or Switzerland;”;
““national”, in relation to an EEA State, means the same as in the Community Treaties, but does not include a person who by virtue of Article 2 of Protocol No. 3 (Channel Islands and Isle of Man) to the Treaty of Accession is not to benefit from Community provisions relating to the free movement of persons and services;”;
““the Pharmacists Recognition Directive” means Council Directive 85/433/EEC concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy as amended by—
Council Directives 85/584/EEC and 90/658/EEC;
the Act annexed to the Treaty relating to the accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden to the European Union signed at Corfu on 24th June 1994, as adjusted by the Decision of the Council of the European Union of 1st January 1995 adjusting the instruments concerning the accession of new Member States to the European Union;
Directive 2001/19/EC; and
the Swiss Agreement;”;
““the Swiss Agreement” means the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other, on the free movement of persons, signed at Luxembourg on 21st June 1999;”;
(8) For Schedule 1A (qualifying European diplomas), substitute the Schedule 1A set out in Schedule 3 to these Regulations.