Changes from plenary report to adopted text

Added3. If a herbal substance, preparation or a combination is no longer included in the list referred to in paragraph 1, registrations pursuant to paragraph 2 for herbal medicinal products containing this substance shall be revoked unless the particulars and documentations referred to in Article 136(1) are submitted within three months.

AddedArticle 140 Other requirements for traditional herbal medicinal products

Added1. Article 1(5), points (a) and (b) and Article 1(10), point (c), Articles 6 to 8, 29, 30, 44, 46, 90, 155, Article 188, paragraphs 1 and 11, Articles 191, 195, 196, 198, 199(2), 202, 203 and 204 and Chapters IX and XI of this Directive as well as Commission Directive 2003/94/EC shall apply, mutadis mutandis, to traditional-use registrations granted under this Section.

Added2. In addition to the requirements set out in Articles 63 to 66, 70 to 79 and Annex IV, any labelling and package leaflet of a traditional herbal medicinal product shall contain a statement to the effect that:

Added(a) the product is a traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use; and

Added(b) the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the traditional herbal medicinal product or if adverse effects not mentioned in the package leaflet occur. ; and [Am. 272]

Added(ba) the user consult a doctor or a qualified healthcare practitioner for information about possible contraindications or pharmacological interactions with other medications. [Am. 273]

AddedA Member State may require that the labelling and the package leaflet shall also state the nature of the tradition in question.

Added3. In addition to the requirements set out in Chapter XIII, any advertisement for a traditional herbal medicinal product registered under this Section shall contain the following statement: Traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use. For more information, consult a healthcare professional. [Am. 274]

AddedArticle 141 Herbal medicinal products working group

Added1. A herbal medicinal products working group is established as referred to in Article 142 of [revised Regulation (EC) No 726/2004]. That working group shall be part of the Agency and shall have the following competence:

Added(a) as regards traditional-use registrations, to:

Added(i) perform the tasks arising from Article 136, paragraphs 1 and 3;

Added(ii) perform the tasks arising from Article 137;

Added(iii) prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 139(1);

Added(iv) establish Union monographs for traditional herbal medicinal products, as referred to in paragraph 3;

Added(b) as regards marketing authorisations of herbal medicinal products, to establish Union herbal monographs for herbal medicinal products, as referred to in paragraph 3;

Added(c) as regards referrals to the Agency under Chapter III, Section 5, or Article 95, in relation to traditional herbal medicinal products as referred to in Article 134, to perform the tasks set out in Article 41;

Added(d) where a matter concerning medicinal products, other than the traditional-use medicinal products, other medicinal products containing herbal substances is referred to the Agency under Chapter III, Section 5, or Article 95, to give an opinion on the herbal substance, where appropriate.

AddedAppropriate coordination with the Committee for Human Medicinal Products for Human Use shall be ensured by a procedure to be determined by the Executive Director of the Agency in accordance with Article 145(10) of [revised Regulation (EC) No 726/2004].

Added2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate to the herbal medicinal working group.

AddedThe alternates shall represent and vote for the members in their absence. Members and alternates shall be chosen for their role and experience in the evaluation of herbal medicinal products and shall represent the competent authorities of the Member States.

AddedThe members of the herbal medicinal products working group may be accompanied by experts in specific scientific or technical fields.

Added3. The herbal medicinal products working group shall establish Union herbal monographs for herbal medicinal products with regard to the application submitted in accordance with of Article 13 as well as traditional herbal medicinal products.

AddedWhere the Union herbal monographs have been established, they shall be taken into account by the competent authorities of Member States when examining an application. Where no such Union herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to.

AddedWhen new Union herbal monographs are established, the traditional-use registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The traditional-use registration holder shall notify any such modification to the competent authority of the Member State concerned.

AddedThe herbal monographs shall be published.

Added4. Provisions of Article 146, paragraphs 3 to 5 of the [revised Regulation (EC) No 726/2004] applying to the working party shall apply by analogy to herbal medicinal products working group.

Added5. The herbal medicinal products working group shall draft its rules of procedure.

AddedChapter XI Manufacturing and import

AddedSection 1 Manufacturing and import of medicinal products

AddedArticle 142 Manufacturing authorisation

Added1. Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to authorisation (the “manufacturing authorisation”). The manufacturing authorisation shall be required also if the medicinal products manufactured are intended for export.

Added2. The manufacturing authorisation referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.

Added3. By derogation from paragraph 2, the manufacturing authorisation shall not be required for the following:

Added(a) preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail and hospital supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes; or [Am. 275]

Added(b) decentralised sites carrying out manufacturing or testing steps under the responsibility of the qualified person of a central site referred to in Article 151(3).

Added4. A manufacturing authorisation shall also be required for imports of medicinal products coming from third countries into a Member State.

AddedThis Chapter and Articles 195(5) and 198 shall apply to imports of medicinal products from third countries.

Added5. Member States shall enter the information relating to the manufacturing authorisation referred to in paragraph 1 in the Union database referred to in Article 188(15).

AddedArticle 143 Requirements for a manufacturing authorisation

Added1. In order to obtain the manufacturing authorisation, the applicant shall submit an application by electronic means to the competent authority of the Member State concerned.

AddedThat application shall include the following particulars:

Added(a) the medicinal products, the pharmaceutical forms and the manufacturing operations that are to be manufactured, imported or carried out and the place where the activity will take place;

Added(b) proof that the applicants have at their disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements that the Member State concerned lays down as regards both manufacture and control and the storage of medicinal products, in accordance with Article 8;

Added(c) proof that the applicants have at their disposal the services of at least one qualified person within the meaning of Article 151;

Added(d) explanation on whether the site is the central site responsible for the oversight of decentralised sites.

Added2. The applicant shall provide, by electronic means, particulars in support of the above in their application.

AddedArticle 144 Granting of a manufacturing authorisation

Added1. The official representatives of the competent authority of the Member State concerned shall carry out an inspection to ensure the accuracy of the particulars included in the application submitted in accordance with Article 143.

AddedWhere the accuracy of the particulars is confirmed in accordance with the first subparagraph and no later than 90 days after the receipt of the application submitted in accordance with Article 143, the competent authority of the Member State shall grant or refuse a manufacturing authorisation.

Added2. To ensure that the particulars referred to in Article 143 are duly submitted, the competent authority of the Member State may grant a manufacturing authorisation subject to conditions.

AddedFor central sites, a manufacturing authorisation shall include for each decentralised site a written confirmation that the manufacturer of the medicinal product has verified compliance of the decentralised site with principles of good manufacturing practice referred to in Article 160 by conducting regular audits in accordance with Article 147(1), first subparagraph, point (f).

Added3. The manufacturing authorisation shall apply only to the medicinal products, pharmaceutical forms, the manufacturing operations and the premises specified in the application and to the premises of the corresponding central site where decentralised manufacturing or testing activities are carried out in decentralised sites, which are registered in accordance with Article 148.

AddedArticle 145 Changes in a manufacturing authorisation

AddedIf the manufacturing authorisation holder requests a change in any of the particulars referred to in Article 143(1), second subparagraph, the competent authority of the Member State shall amend the manufacturing authorisation no later than 30 days from such request. In exceptional cases this period of time may be extended to 90 days.

AddedArticle 146 Request for additional information

AddedThe competent authority of the Member State may request the applicant to submit additional information on the particulars supplied pursuant to Article 143(1) and on the qualified person referred to in Article 151; where the competent authority of the Member State makes such request, the time limits referred to in Articles 144(1), second subparagraph, and 145 shall be suspended until the additional information has been supplied.

AddedArticle 147 Obligations of the manufacturing authorisation holder

Added1. Member States shall ensure that manufacturing authorisation holders shall: