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[F1PART 12AU.K.Sale of medicines to the public at a distance

Textual Amendments

F1Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28

[F2Application of PartU.K.

256ZA.  This part applies to Northern Ireland only.]

Textual Amendments

InterpretationU.K.

256A.—[F3(1)] In this Part—

“common logo” means the common logo that is required to be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with the requirements laid down in the implementing acts adopted by the Commission under Article 85c(3) of the 2001 Directive;

“information society services” means information society services as defined in Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;

“the list” means the list of persons who are entitled to supply medicinal products by information society services that is maintained on the website of the [F4licensing authority];

F5...

“website of the EMA” means the website of the EMA that—

(a)

gives explicit information to the viewer on the [F6website of the licensing authority] containing information on persons authorised or entitled to supply medicinal products at a distance in [F7Northern Ireland];

(b)

provides information on the purpose of the common logo;

(c)

provides background information about the risks related to medicinal products supplied illegally to the public by means of information society services;

(d)

provides information on Community legislation applicable to falsified medicinal products;

(e)

contains [F8a hyperlink to the website of the licensing authority].

[F9“website of the licensing authority” means a website of the licensing authority providing information on—

(a)

the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services;

(b)

the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply;

(c)

the purpose of the common logo;

(d)

the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses;

(e)

background information about the risks related to medicinal products supplied illegally to the public by means of information society services;

(f)

a hyperlink to the website of the EMA;]

[F10(2) In this Part, references to selling a medicinal product at a distance to the public by means of information society services, however expressed, include supplying and offering to sell or supply a medicinal product at a distance to the public by means of information society services (and related expressions are to be interpreted accordingly).]

Textual Amendments

F3 Reg. 256A renumbered as reg. 256A(1) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 13(a) and reg. 256A renumbered as 256A(1) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 13(a)

Person who may sell medicinal products by information society servicesU.K.

256B.—[F11(A1) This regulation applies to a person who is an established service provider (as defined in regulation 2(1) of the Electronic Commerce (EC Directive) Regulations 2002) in Northern Ireland.]

(1) A person may not sell a medicinal product at a distance to the public by means of information society services unless that person satisfies the following conditions.

(2) Condition A is that the person is included on the list F12....

[F13(3) Condition B is that the product to be sold by information society services is covered by a UK marketing authorisation or an authorisation granted—

(a)under Regulation (EC) No 726/2004; or

(b)by a competent authority of the member State in which that product is destined to be sold.

(3A) Condition B does not apply to—

(a)a special medicinal product;

(b)a medicinal product where the product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968; or

(c)a medicinal product where—

(i)the product is a result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

(ii)regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

(iii)the process of assembly results in a change in the presentation of the authorised medicinal product; and

(iv)by reason of the change in paragraph (iii) the product does not comply with condition B.]

(4) Condition C is that the person selling the medicinal product is authorised or entitled to sell to the public, including by information society services, medicinal products of that type or classification F14....

(5) Condition D is that where the sale is to a member of the public in the United Kingdom, it is in accordance with regulations 214 (sale or supply of prescription only medicines), 220 (sale or supply of medicinal products not subject to general sale) and 221 (sale or supply of medicinal products subject to general sale).

(6) Condition E is that the person selling the medicinal product has given a valid notification to [F15the licensing authority].

(7) Condition F is that the person selling medicinal products at a distance complies with the relevant provisions of the Electronic Commerce (EC Directive) Regulations 2002.

(8) A person has not given a valid notification for the purposes of paragraph (6) if—

(a)that person is not included on the list;

(b)[F16that person’s entry on the list] is suspended by [F17the licensing authority]; or

(c)[F18the licensing authority] has been notified under regulation 256E(b) to remove that person from the list.

Textual Amendments

F13Reg. 256B(3)(3A) substituted for reg. 256B(3) (31.12.2020) by S.I. 2019/775, reg. 197(3)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F16Words in reg. 256B(8)(b) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 14 and words in reg. 256B(8)(b) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 14

Notification requirements for sellers of medicinal products at a distanceU.K.

256C.—(1) The [F19licensing authority] may not enter a person’s details on the list unless it has been notified in accordance with paragraphs to (5).

(2) The notification must include—

(a)the name or corporate name of the person to be listed;

(b)information about—

(i)that person’s permanent address from which the activity of selling medicinal products by information society services is to be carried out,

(ii)the commencement date of the activity of selling medicinal products by information society services,

(iii)the address of the website used for the purposes of selling medicinal products by information society services,

(iv)all relevant [F20information] necessary to identify the website, and

(v)information about the classification of all the medicinal products offered for sale at a distance.

(3) The notification shall—

(a)be in English; and

(b)unless paragraph (4) applies, in relation to the person whose details are to be entered on the list—

(i)be signed by that person, and

(ii)contain that person’s telephone number and e-mail address if this is available.

(4) Where the notification is made by another person (“A”) on behalf of the person whose details are to be entered on the list, the notification shall—

(a)contain the name and address of A;

(b)be signed by A; and

(c)contain the telephone number and e-mail address for A if this is available.

(5) The notification shall contain contact details for the site from which the activity of selling medicinal products by information society services is to be carried out including the—

(a)site address;

(b)name of person who may be contacted; and

(c)the telephone number and e-mail address of the person who may be contacted.

Textual Amendments

Procedure for listing persons who may supply medicinal products at a distanceU.K.

256D.—(1) If the [F19licensing authority] receives a notification under regulation 256C it must accept or refuse to include that person on the list within the period of 90 days beginning immediately after the day on which the notification is received by the authority.

(2) Paragraph (1) applies only if the requirements of regulation 256C(2) have been met.

(3) Before determining if a person can be included on the list, the [F19licensing authority] may require the person giving the notification to provide such information as [F21the licensing authority] thinks necessary, within the period specified by [F21the licensing authority].

(4) If a notice under paragraph (3) requires the person giving the notification to provide the [F19licensing authority] with information, the information period is not to be counted for the purposes of paragraph (1).

(5) In paragraph (4), the “information period” means the period—

(a)beginning with the day on which the notice is given, and

(b)ending with the day on which—

(i)the [F19licensing authority] receives the information; or

(ii)the person from whom the information is requested shows to the satisfaction of the [F19licensing authority] that the information cannot be provided.

(6) The [F19licensing authority] must give the person giving the notification a notice stating reasons for its decision in any case where—

(a)the [F19licensing authority] refuses to include the person giving the notification on the list; or

(b)if the [F19licensing authority] lists the person giving the notification otherwise that in accordance with the information supplied in the notification.

Textual Amendments

Removal of a person’s entry from the listU.K.

256E.  The [F19licensing authority] may remove a person’s entry from the list if—

(a)regulation [F22256I(1)(c)] applies; or

(b)a notification to remove the entry is received from the person on the list.

Textual Amendments

F22Word in reg. 256E(a) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 8 and word in reg. 256E(a) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 8

Provision of information to the [F19licensing authority] U.K.

256F.—(1) A person on the list must immediately inform the [F19licensing authority] and, where applicable, the marketing authorisation holder, of medicinal products which that person—

(a)identifies as;

(b)knows or suspects; or

(c)has reasonable grounds for knowing or suspecting,

to be falsified.

(2) The person entered on the list must notify the [F19licensing authority] of any change of circumstances which is material as regards that person’s entry on the list.

(3) The [F19licensing authority] may give a notice to a person on the list, requiring that person to provide information of a kind specified in the notice within the period specified in the notice.

(4) A notice under paragraph (3) may not be given to a person on the list unless it appears to the [F19licensing authority] that it is necessary for that competent authority to consider whether that person’s entry on the list should be varied, suspended or removed.

(5) A notice under paragraph (4) may specify information which the [F19licensing authority] thinks necessary for considering whether the person’s entry on the list should be varied, suspended or removed.

Textual Amendments

Grant or refusal to list a personU.K.

256G.—(1) On receipt of a notification from a person to be included in the list—

(a)the [F19licensing authority] must include that person on the list if that person complies with the requirements in regulation 256C(2) to (5); or

(b)if it considers necessary or appropriate to do so, the [F19licensing authority] must refuse to include that person on the list having had regard to—

(i)the provisions of these Regulations, and

(ii)any EU obligation.

(2) The [F19licensing authority] must give a notice stating the reasons for its decision in any case where [F23the licensing authority]—

(a)refuses to include a person on the list; or

(b)includes a person in the list otherwise than in accordance with the notification and that person requests a statement of its reasons.

(3) Where the [F19licensing authority] decides to include a person on the list [F24the licensing authority] must ensure that the [F25website of the licensing authority] includes—

(a)the name or corporate name of the person that is listed; and

(b)the person’s website address in the United Kingdom.

Textual Amendments

F24Words in reg. 256G(3) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 197(7)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)

F25Words in reg. 256G(3) substituted (31.12.2020) S.I. 2019/775, regs. 1, 197(7)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 S.I. 2020/1488, reg. 1, Sch. 2 para. 151)

Conditions to be met by a person entered on the listU.K.

256H.—(1) A person entered on the list shall not sell a medicinal product at a distance by information society services unless the following conditions are satisfied.

(2) Condition A is that the person entered on the list must comply with regulation 256B.

(3) Condition B is that without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market, (Directive on electronic commerce), the website used to sell medicinal products at a distance must contain—

(a)the contact details of the [F19licensing authority] F26...;

(b)a hyperlink to the [F27website of the licensing authority].

(4) Condition C is that without prejudice to any implementing Acts adopted by the Commission under Article 85c(3) of the 2001 Directive the website used to sell medicinal products at a distance must contain the common logo which—

(a)is clearly displayed on every page of the listed person’s website that relates to medicinal products offered for sale at a distance; and

(b)contains a hyperlink to the entry of that person in the list.

Textual Amendments

Power to suspend, vary or remove a person’s entry on the listU.K.

256I.—(1) The [F19licensing authority] may in accordance with regulation 256J—

(a)suspend a person’s entry on the list for such period as the authority thinks fit;

(b)vary a person’s entry on the list; or

(c)remove a person’s entry from the list.

(2) The suspension of person from the list may be—

(a)total;

(b)limited to medicinal products of one or more descriptions; or

(c)limited to medicinal products sold at a distance from specified premises or a specified part of any premises.

(3) The power conferred by this regulation may only be exercised on one or more of the following grounds—

(a)in relation to any information notified to the [F19licensing authority] under regulation 256C as a result of which the person was included in the list—

(i)the information so supplied was false or incomplete in a material respect,

(ii)a material change of circumstances has occurred in relation to any of the matters stated in the notification;

(b)the person on the list has materially contravened a condition required to be met by a person entered on the list under regulation 256H; or

(c)the person on the list has without reasonable excuse failed to supply information to the [F19licensing authority] with respect to their notification when required to do so under regulation 256F(3).

Textual Amendments

Procedure where the [F19licensing authority] proposes to suspend, vary or remove a person’s entry on the listU.K.

256J.—(1) This regulation applies where—

(a)the provisions of regulation 256K do not apply; and

(b)the [F19licensing authority] proposes to exercise the power in regulation 256I.

(2) The [F19licensing authority] must notify the person on the list in writing of—

(a)its proposal;

(b)the reasons for it; and

(c)a specified date on which it is proposed that the suspension, variation or revocation should take effect.

(3) The specified date in paragraph (2)(c) must be no earlier than 28 days following the date of the notice given by the [F19licensing authority].

(4) The person to whom notice is given under paragraph (2) may before the date specified in the notice—

(a)make written representations to the [F19licensing authority] with respect to the proposal; or

(b)notify the [F19licensing authority] that the person wishes that competent authority to submit the proposal to review upon oral representations.

(5) If person on the list makes written representations in accordance with sub-paragraph (4)(a) the [F19licensing authority] must take those representations into account before making a decision in the matter.

(6) If the person on the list gives notice of the proposal to review upon oral representation in accordance with paragraph (4)(b)—

(a)Schedule 5 has effect; F28...

F28(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) If the [F19licensing authority] proceeds to suspend, vary or remove a person’s entry on the list in accordance with the provisions of regulation 256I it must give a notice to that person.

(8) The notice must—

(a)give particulars of the suspension, variation or removal; and

(b)give reasons for the decision to suspend, vary or remove the person’s entry on the list.

(9) Paragraphs (7) and (8) are without prejudice to any requirement of Schedule 5 as to notification.

Textual Amendments

Suspension of a person’s entry on the list in cases of urgencyU.K.

256K.—(1) The [F19licensing authority] may immediately suspend a person’s entry on the list for a period not exceeding three months where it appears to [F29the licensing authority] that in the interests of safety it is appropriate to do so.

(2) This paragraph applies where—

(a)a person’s entry on the list has been suspended under paragraph (1); and

(b)it appears to the [F19licensing authority] that it is necessary to consider whether the person’s entry on the list should be—

(i)further suspended or varied, or

(ii)removed from the list.

(3) Where paragraph (2) applies, the [F19licensing authority] must proceed as set out in regulation 256I (but this is subject to paragraph (4)).

(4) Paragraph (5) applies where, in circumstances where paragraph (2) applies, the [F19licensing authority] proceeds as set out in regulation 256I and any proceedings under that regulation have not been finally disposed of before the end of the period for which the person’s entry was suspended under paragraph (1) or further suspended under paragraph (5).

(5) If it appears to the [F19licensing authority] to be necessary in the interests of safety to do so, the authority may further suspend the person’s entry on the list for a period which (in the case of each further suspension) is not to exceed three months.

(6) In the event that any challenge against a decision under regulation 256I to suspend, vary or remove a person’s entry on the list is made on an application under regulation 322(4) (validity of decisions and proceedings), paragraph (5) shall apply, but this is without prejudice to regulation 322(6)(a) (interim order of the High Court).

Textual Amendments

Variation of a person’s entry on the list on the application of that personU.K.

256L.—(1) This regulation applies if a person entered on the list applies to the [F19licensing authority] for a variation of the person’s entry on the list.

(2) The application must—

(a)be in writing;

(b)specify the variation requested;

(c)be signed by or on behalf of the applicant; and

(d)be accompanied by such information as may be required to enable the [F19licensing authority] to consider the application.

(3) The [F19licensing authority] must vary a person’s entry on the list or refuse to vary it within 30 days beginning with the day after the date when [F30the licensing authority] receives the application.

(4) The [F19licensing authority] may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the [F19licensing authority] with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a)beginning with the day on which notice under paragraph (4) is given; and

(b)ending with the day on which the [F19licensing authority] receives the information or the applicant shows to [F31the licensing authority's] satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 256I and 256K.

Textual Amendments

Offences: breach of regulations and false informationU.K.

256M.—(1) A person is guilty of an offence if the person—

(a)contravenes regulation 256B(1); or

(b)offers medicinal products for sale at a distance otherwise than in accordance with the conditions in regulation 256H.

(2) A person is guilty of an offence if the person knowingly gives false information in—

(a)an application to be entered on the list in accordance with regulation 256C(2);

(b)an application for a variation in accordance with regulation 256L(2); or

(c)response to a notice under regulation 256L(4).

(3) A person is guilty of an offence if, without reasonable excuse, the person fails to comply with a notice under regulation 256F(3) or 256L(4).

(4) A person is guilty of an offence if that person fails to inform the [F19licensing authority]—

(a)of a falsified medicinal product in accordance with regulation 256F(1); or

(b)about a material change of circumstances in accordance with regulation 256F(2).

(5) It is a defence for a person charged with an offence under paragraph (4) to show that the person exercised all due diligence to avoid committing the offence.

Textual Amendments

PenaltiesU.K.

256N.—(1) A person guilty of an offence under regulation 256M(1), (2) or (4) is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

(2) A person guilty of an offence under regulation 256M(3) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.]