| 《欧盟传统植物药（草药）注册程序指令》 |
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| 2004-05-17 13:29 |
DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
欧洲议会和理事会2004/24/EC指令
of 31 March 2004
2004年3月31日
amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on theCommunity code relating to medicinal products for human use
对欧共体人用药品2001/83/EC指令中关于传统草药产品部分的修订
（中文由商务部科技司翻译整理，仅供参考）
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Economic and
Social Committee (2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
欧盟欧洲议会和理事会
遵照欧共体条约，特别是其中的第95条，
遵照欧委会的提议
遵照经济和社会委员会的意见
依照条约第251条项下规定的程序
Whereas:
(1) Directive 2001/83/EC (4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.
鉴于：
（1）2001/83/EC指令规定：欲获得药品市场准入的申请者，应提供详细技术资料和文件，它们应包括产品的理化，生物或微生物、药理、毒理和临床试验结果，以证明产品的质量、安全和有效性。
(2) Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC, he/she should not be required to provide the results of pre-clinical tests or the results of clinical trials.
（2）若申请者能利用发表的详细的科学文献，阐述药品的单一成分或多个成分具有确切的医疗用途，且确认其疗效以及具有可接受的安全水平，根据2001/83/EC指令的要求，可以不必提供临床前或临床研究结果。
(3) A significant number of medicinal products, despite their long tradition, do not fulfil the requirements of a well-established medicinal use with recognised efficacy and an acceptable level of safety and are not eligible for a marketing authorisation. To maintain these products on the market, the Member States have enacted differing procedures and provisions. The differences that currently exist between the provisions laid down in the Member States may hinder trade in traditional medicinal products within the Community and lead to discrimination and distortion of competition between manufacturers of these products. They may also have an impact on the protection of public health since the necessary guarantees of quality, safety and efficacy are not always provided at present.
（3）大量的药品，尽管它们有很长的历史，如果不能满足具有肯定的医疗用途、确切的疗效和可接受的安全性的要求，也得不到上市许可。为了保持这些药品在市场上的流通，成员国已经颁布了不同的注册程序和管理办法。各成员国现有这些法规上的差别可能会阻碍共同体内这些药品的贸易，并导致这些产品生产者间的歧视和不规则竞争，这也可能会对公众健康保护产生影响，因为目前药品的质量、安全和有效性不总能得到必要的保证。
(4) Having regard to the particular characteristics of these medicinal products, especially their long tradition, it is desirable to provide a special, simplified registration procedure for certain traditional medicinal products. However, this simplified procedure should be used only where no marketing authorisation can be obtained pursuant to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety. It should likewise not apply to homeopathic medicinal products eligible for marketing authorization or for registration under Directive 2001/83/EC.
（4）考虑到这些药品的特殊性质，特别是具有悠久的应用历史，对某些传统药品提供一个专门的、简化注册程序是必要的。然而，这种简化程序仅仅适合于在2001/83/EC指令中不能获得上市批准的药品，特别是那些由于缺少足够的科学文献来证实其疗效的确切性及其安全性达到可接受水平者。它同样不适合根据2001/83/EC指令可以获得市场准入或注册的顺势疗法药品。
(5) The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Pre-clinical tests do not seem necessary, where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use. However, even a long tradition does not exclude the possibility that there may be concerns with regard to the product's safety, and therefore the competent authorities should be entitled to ask for all data necessary for assessing the safety. The quality aspect of the medicinal product is independent of its traditional use so that no derogation should be made with regard to the necessary physico-chemical, biological and microbiological tests. Products should comply with quality standards in relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a Member State.
（5）具有悠久应用史的药品，可以免做临床试验，因为基于长期应用和实践而得出药品的有效性似乎是有理的。依据药品的传统应用信息，在特定情况下使用证明它们不是有害的，其临床前研究似乎是不必要的。然而，即便是悠久的传统应用史也不能排除对产品安全性的担心，因此主管当局有权要求提供所有必要的资料以评价其安全性。药品质量方面的要求与传统应用无关，因此有关药品必要的理化、生物学和微生物学的试验是不能缺少的。产品质量应符合欧洲药典专论或成员国的药典要求。
(6) The vast majority of medicinal products with a sufficiently long and coherent tradition are based on herbal substances. It therefore seems appropriate to limit the scope of the simplified registration in a first step to traditional herbal medicinal products.
（6）由于有悠久历史和长期应用的大量传统药品是以草药物质为基础的。所以，首先进行简化注册的范围仅限于传统草药产品看来是合适的。
(7) The simplified registration should be acceptable only where the herbal medicinal product may rely on a sufficiently long medicinal use in the Community. Medicinal use outside the Community should be taken into account only if the medicinal product has been used within the Community for a certain time. Where there is limited evidence of use within the Community, it is necessary to assess carefully the validity and relevance of use outside the Community.
（7）简化注册只应接受在共同体内有长期临床应用的草药产品。那些共同体之外应用的产品，只有在共同体内已应用一段时间，才能考虑简化注册。如果在共同体内使用的时间有限，在使用共同体外的使用纪录时，应注意纪录的有效性和实用性。
(8) With the objective of further facilitating the registration of certain traditional herbal medicinal products and of further enhancing harmonisation, there should be the possibility of establishing a Community list of herbal substances that fulfil certain criteria, such as having been in medicinal use for a sufficiently long time, and hence are considered not to be harmful under normal conditions of use.
（8）为了进一步便于某些传统草药产品注册并加强协调，有可能建立一个共同体的草药物质目录，该目录中的草药物质要达到一定的标准，例如，具有足够长的药用历史，从而在正常使用下似乎是无害的。
(9) Having regard to the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products should be established within the European Agency for the Evaluation of Medicinal Products (hereinafter ‘the Agency’) set up by Council Regulation (EEC) No 2309/93 (1). The Committee should carry out tasks concerning the simplified registration and authorization of medicinal products as provided for in this Directive. Its tasks should relate in particular to establishing Community herbal monographs relevant for the registration as well as the authorisation of herbal medicinal products. It should be composed of experts in the field of herbal medicinal products.
（9）考虑到草药产品的特性，应根据理事会2309/93号文件在欧盟药品审评中心（下文：简称药审中心）内部设立一个草药产品的专门委员会。该委员会应根据本指令承担草药产品的上市批准和注册方面的工作。其任务主要是建立适用于草药产品注册和授权的共同体草药专论。该委员会应由草药产品领域的专家组成
(10) It is important to ensure full consistency between the new Committee and the Committee for Human Medicinal Products already existing within the Agency.
（10）保证新委员会和药审中心目前的人用药品委员会的完全一致是非常重要的。
(11) In order to promote harmonisation, Member States should recognise registrations of traditional herbal medicinal products granted by another Member State based on Community herbal monographs or consisting of substances, preparations or combinations thereof contained in a list to be established. For other products, Member States should take due account of such registrations.
（11）为了促进成员国之间的一致性，成员国对于另一个成员国根据共同体草药专论或是对于已被列在将建立的目录中的物质、制剂或化合物而注册的草药应予认可。对于上述两种情况之外的，成员国对于另一个成员国注册决定应予考虑。
(12) This Directive allows non-medicinal herbal products, fulfilling the criteria of food legislation, to be regulated under food legislation in the Community.
（12）本指令允许符合食品法规的非药用植物产品依据共同体的食品法规进行管理。
(13) The Commission should present a report on the application of the chapter on traditional herbal medicinal products to the European Parliament and to the Council including an assessment on the possible extension of traditional-use registration to other categories of medicinal products.
（13）欧盟委员会应给欧洲议会和理事会提交一个有关传统草药产品法规部分的申请报告，其中包括简化注册扩展到其它类药品可能性的评估报告。
(14) It is therefore appropriate to amend Directive 2001/83/EC accordingly,
（14）因此，应适当修订2001/83/CE指令。
HAVE ADOPTED THIS DIRECTIVE:
已经采纳该指令：
Article 1
第1条
Directive 2001/83/EC is hereby amended as follows:
指令2001/83/EC修订如下：
1. in Article 1 the following is added:
1、在第1条中加入：
‘29. Traditional herbal medicinal product:
a herbal medicinal product that fulfils the conditions laid down in Article 16a(1);
“29、传统草药产品
满足了第16a（1）条规定条件的草药产品；
30. Herbal medicinal product:
any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;
30、草药药品
以一种或多种草药物质、一种或多种草药制剂、以及一种或多种草药物质与一种或多种草药制剂复方作为活性组份的任何一种药用产品；
31. Herbal substances:
All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author);
31、草药物质：
所有未经加工的植物全株、片段或切制的植物、植物部位、藻类、真菌和苔藓类，都可称为草药物质，它们通常是干燥状态，但有时也是新鲜的。不经特殊处理的某些分泌物也可作为草药物质。草药物质依使用的植物部位来定义，植物名依照双命名系统（属，种，变种和命名人）命名。
32. Herbal preparations:
preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.’
32、草药制剂：
由草药物质制备而得到，制备方法如萃取、蒸馏、压榨、分馏、纯化、浓缩和发酵。这些草药制剂包括粉碎或粉状的草药物质、酊剂、提取物、挥发油、压榨汁和经加工的分泌物等。
2. The following chapter is inserted in Title III:
2、下述章节插入第III篇中
‘CHAPTER 2a
章节2a:
Specific provisions applicable to traditional herbal medicinal products
适用于传统草药产品的具体条款
Article 16a
第16a条
1. A simplified registration procedure (hereinafter “traditional-use registration”) is hereby established for herbal medicinal products which fulfil all of the following criteria:
1、完全满足如下标准的草药产品，适用简化注册程序（下称“传统应用注册”）。
(a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;
(a)它们有适合于传统草药产品的独特适应症，这些传统草药产品的组成和用途，被设计为不需从业医师的诊断、处方或监督等干预下就能使用；
(b) they are exclusively for administration in accordance with a specified strength and posology;
(b) 它们有与特定作用强度和剂量相符的特定服用方法。
(c) they are an oral, external and/or inhalation preparation;
(c) 它们是口服、外用和/或吸入制剂。
(d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed;
(d) 已过第16c (1)(c)条规定的传统应用期。
(e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.
(e) 药品的传统应用资料是充分的，特别是产品被证明在指定的条件下使用是无害的，在长期使用和经验的基础上，其药理作用或药效似乎是有道理的。
2. Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).
2、尽管1（30）条中已做出规定，但是对于含有维生素或矿物质的草药产品，如果有证据证明其安全性，而且如果维生素或矿物质对于植物活性成分具有特别重要的辅助作用，可以根据第一段的要求进行注册。
3. However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall not apply.
3、然而，如果主管当局判定某传统草药产品符合第6条上市许可标准或第14条注册标准，则不适用本章的条款。
Article 16b
第16b条
1. The applicant and registration holder shall be established in the Community.
1、申请者和注册持有者必须在共同体范围内。
2.In order to obtain traditional-use registration, the applicant shall submit an application to the competent authority of the Member State concerned.
2、为了获得传统应用注册，申请者必须向有关成员国主管当局提交申请。
Article 16c
第16c条
1. The application shall be accompanied by:
1、申请应附有下列资料：
(a) the particulars and documents:
（a）相关详细资料和文件
(i) referred to in Article 8(3)(a) to (h), (j) and (k);
(i) 遵照第8条(3)(a)到(h),(j)和(k)
(ii) the results of the pharmaceutical tests referred to in the second indent of Article 8(3)(i);
(ii) 依照第8条(3) (i)第二段的药学试验结果
(iii) the summary of product characteristics, without the data specified in Article 11(4);
(iii) 产品特性概要，不含第11条(4)中规定的详细数据。
(iv) in case of combinations, as referred to in Article 1(30) or Article 16a(2), the information referred to in Article 16a(1)(e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data shall also relate to the individual active ingredients;
(iv)对于第1条(30)或第16条a(2)中所论述的草药复方，应提供第16条a (e)中对复方所要求的信息资料。如果该复方中单味药的活性成分尚不完全清楚，这些信息资料也需要与单味药的活性成分相关联。
(b) any authorisation or registration obtained by the applicant in another Member State, or in a third country, to place the medicinal product on the market, and details of any decision to refuse to grant an authorisation or registration, whether in the Community or a third country, and the reasons for any such decision;
（b）申请者为将药品投放市场在另一成员国或成员国以外的第三国获得的市场准入批准或注册批准[证件]，以及有关拒绝给予市场准入批准或注册批准决定的详细资料（无论是成员国或成员国以外的第三国）和作出该决定的理由。
(c) bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community. At the request of the Member State where the application for traditional-use registration has been submitted, the Committee for Herbal Medicinal Products shall draw up an opinion on the adequacy of the evidence of the long-standing use of the product, or of the corresponding product. The Member State shall submit relevant documentation supporting the referral;
（c） 待批药品或同类相关药品功效的文献或专家证据。它们是指在申请日之前已有至少30年的药用历史，包括在共同体内至少15年的使用历史。成员国接到传统使用注册的申请后，在成员国的要求下，草药产品委员会应对于该产品或相关产品长期应用的证明是否充分提出意见。成员国应提交相关文件。
(d) a bibliographic review of safety data together with an expert report, and where required by the competent authority, upon additional request, data necessary for assessing the safety of the medicinal product.
（d） 安全性数据的文献综述和专家报告，以及主管当局额外要求的用以评价药品安全性的必需材料。
Annex I shall apply by analogy to the particulars and documents specified in point (a).
附件一同样适用于(a)中规定的资料和文件。
2. A corresponding product, as referred to in paragraph 1(c), is characterised by having the same active ingredients, irrespective of the excipients used, the same or similar intended purpose, equivalent strength and posology and the same or similar route of administration as the medicinal product applied for.
2、第1段（c）中所指的同类相关产品是指具有相同的活性成分（不考虑所使用的赋形剂）、相同或相似的治疗目的、相同作用强度和剂量以及相同或相似的给药途径。
3. The requirement to show medicinal use throughout the period of 30 years, referred to in paragraph 1(c), is satisfied even where the marketing of the product has not been based on a specific authorisation. It is likewise satisfied if the number or quantity of ingredients of the medicinal product has been reduced during that period.
3、即使是没有经过特定许可而在市场流通的产品，也符合第1段（c）中提及的已有30年的药用历史的要求。在该应用期间即使产品中组分的数目或剂量已有减少，同样也符合要求。
4. Where the product has been used in the Community for less than 15 years, but is otherwise eligible for simplified registration, the Member State where the application for traditional-use registration has been submitted shall refer the product to the Committee for Herbal Medicinal Products. The Member State shall submit relevant documentation supporting the referral.
The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be taken into account by the Member State when taking its final decision.
4、如果产品在共同体内应用不足15年，但满足其他申请简易注册的要求，接受传统应用注册申请的成员国，应将产品提交草药产品委员会，并提交相关文件。
委员会应评估第16条a所提及有关简化注册的其它条件是否符合。如果委员会认为可能，将针对该产品起草一个共同体草药专论（第16条h(3)所提及的），成员国应在做出最终决定时，充分考虑该专论的意见。
Article 16d
第16d条
1. Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that:
1、在不违反第16条h(1)的情况下，第三部第4章可同样适用于根据第16条a给予的注册，如果：
(a) a Community herbal monograph has been established in accordance with Article 16h(3), or
已根据16条h(3)建立草药专论
(b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.
草药产品包含的草药物质、制剂或混合物在16条f的目录中
2. For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter.
对于第16条a中所提到的草药产品，成员国在评估传统使用注册的申请时，应根据这一节充分考虑其他成员国已给予的注册。
Article 16e
第16e条
1. Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b or 16c or if at least one of the following conditions is fulfilled:
1、如果申请与第16a，16 b或16c条不符，或是属于下述情况的任何一种，该传统应用注册将被拒绝。
(a) the qualitative and/or quantitative composition is not as declared;
(a) 定性和/或定量组成与声明中不符者；
(b) the indications do not comply with the conditions laid down in Article 16a;
(b)适应症不符合第16 a条规定条件者；
(c) the product could be harmful under normal conditions of use;
(c) 产品在正常条件下使用可能有害者；
(d) the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience;
(d) 传统应用资料不充分，特别是根据长期应用和经验来判断，其药理作用或疗效不确切者；
(e) the pharmaceutical quality is not satisfactorily demonstrated.
(e) 药品的质量没有获得令人满意的证明者。
2. The competent authorities of the Member States shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional-use registration and the reasons for the refusal.
2、成员国主管当局必须通知申请人、欧委会和任何提出要求的主管当局它拒绝传统使用注册的任何决定及拒绝的原因。
Article 16f
第16f条
1. A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products shall be established in accordance with the procedure referred to in Article 121(2). The list shall contain, with regard to each herbal substance, the indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product.
1.应根据121条（2）中规定的程序建立一个在传统草药产品中使用的草药物质、制剂和混合物的目录。该目录应包含每个草药物质的适应症，指定的作用强度和剂量，给药途径和任何其他与草药物质的安全使用有关的必要信息。
2. If an application for traditional-use registration relates to a herbal substance, preparation or a combination thereof contained in the list referred to in paragraph 1, the data specified in Article 16c(1)(b)(c) and (d) do not need to be provided. Article 16e(1)(c) and (d) shall not apply.
2. 如果申请传统应用注册的草药物质、制剂或混合物如第1段中提及的在目录中，就可以不提供第16c (1) (b) (c) 和(d) 条所指定的资料。第16e (1) (c) 和 (d)条 将不适用上述情况。
3. If a herbal substance, preparation or a combination thereof ceases to be 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 documents referred to in Article 16c(1) are submitted within three months.
3. 如果某种草药物质、制剂或混合物从目录（第1段中提及的）中被删除，依照第2段注册的、含有该物质的草药药品将被取消资格，除非按照第16c (1)条的要求，在三个月内提交相关的详细资料和文件。
Article 16g
第16g条
1. Articles 3(1) and (2), 4(4), 6(1), 12, 17(1), 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112, 116 to 118, 122, 123, 125, 126, second subparagraph, and 127 of this Directive as well as Commission Directive 91/356/EEC (*) shall apply, by analogy, to traditional-use registration granted under this chapter.
1、以此类推，本指令的第3 (1)和 (2), 4(4), 6(1),12, 17(1), 19, 20, 23, 24, 25, 40到52, 70到85, 101到108, 111(1) 和 (3), 112, 116到118, 122, 123, 125, 126条第二小段, 127条，以及共同体委员会的91/356/EEC指令 11适用于根据本章节所进行的传统应用注册。
2. In addition to the requirements of Articles 54 to 65, any labelling and user package leaflet shall contain a statement to the effect that:
2. 除了第54 到65条的规定外，任何标签和用户包装说明书应包含一个功效的声明：
(a) the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and
(a) 本产品是仅基于长期使用适用于某适应症的传统草药产品， 而且
(b) the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
(b)在药品的使用过程中，如若症状持续，或出现说明书中未提及的副作用，使用者应当咨询医生或称职的开业医生。
A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question.
成员国应当规定：在标签和用户包装说明书中，也应声明该药品所涉及的使用历史。
3. In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use.
3. 除了第86到99条的要求外，按本章节规定所注册的任何药品的广告应包含如下声明：“传统草药产品适用于某适应症仅基于长期使用”。
Article 16h
1. A Committee for Herbal Medicinal Products is hereby established. That Committee shall be part of the Agency and shall have the following competence:
草药产品委员会据此成立。该委员会是药审中心的一部分并具有如下职能：
(a) as regards simplified registrations, to:
（a）关于简易注册：
— perform the tasks arising from Article 16c(1) and (4),
履行第16条c(1)和(4)规定的职能
— perform the tasks arising from Article 16d,
履行第16条d规定的职能
— prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1), and
遵照第16条f(1)起草草药物质、制剂和混合物的目录草案
— establish Community monographs for traditional herbal medicinal products, as referred to in paragraph 3 of this Article;
遵照本条第三段起草建立共同体传统草药产品专论
(b) as regards authorisations of herbal medicinal products, to establish Community herbal monographs for herbal medicinal products, as referred to in paragraph 3 of this Article;
（b）关于传统草药产品的认可，遵照本条第三段起草建立共同体传统草药产品专论
(c) as regards referrals to the Agency under Chapter 4 of Title III, in relation to herbal medicinal products as referred to in Article 16a, to perform the tasks set out in Article 32;
（c）关于依据第三部第四章向药审中心提交的与第16条a规定的草药产品相关的产品，履行第32条的职责
(d) where other medicinal products containing herbal substances are referred to the Agency under Chapter 4 of Title III, to give an opinion on the herbal substance where appropriate.
（d）含有植物成分的其它药品依据第三部分第4章提交给药审中心时，草药产品委员会应适当地就其草药成分提出意见。
Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law.
最后，草药产品委员会还应履行共同体法律赋予其的其他职责。
The appropriate coordination with the Committee for Human Medicinal Products shall be ensured by a procedure to be determined by the Executive Director of the Agency in accordance with Article 57(2) of Regulation (EEC) No 2309/93.
药审中心的执行主任应根据2309/93法规的第55（2）条制定程序，确保（草药产品委员会）与人用药品委员会之间的适当合作。
2. Each Member State shall appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Herbal Medicinal Products.
2.每个成员国应向草药产品委员会任命一名成员和一名替补成员，任期3年，可连任。
The 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 national authorities.
替补成员在成员缺席的情况下代表成员投票。成员和替补成员的选择应根据他们在草药产品评价方面的职责和经验，并代表国家主管当局。
The said Committee may coopt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
草药产品委员会可以根据个人在所在领域的专长指派最多5名附加成员，任期3年，可连任，但不许替补。
With a view to the coopting of such members, the said Committee shall identify the specific complementary scientific competence of the additional member(s). Coopted members shall be chosen among experts nominated by Member States or the Agency.
在指派上述成员时，草药产品委员会应注意成员个人在所在领域的专长，指派成员可从成员国和药审中心提名的专家中选择。
The members of the said Committee may be accompanied by experts in specific scientific or technical fields.
草药产品委员会成员可以包括特定科学或技术领域的专家
3. The Committee for Herbal Medicinal Products shall establish Community herbal monographs for herbal medicinal products with regard to the application of Article 10(1)(a)(ii) as well as traditional herbal medicinal products. The said Committee shall fulfil further responsibilities conferred upon it by provisions of this chapter and other Community law.
3. 草药产品委员会应建立欧共体关于第[10a] [10(1)(a)(ii)]条申请的草药产品和传统草药产品专论。委员会应履行根据本章条款的规定和其他共同体的法律所授予它的职责。
When Community herbal monographs within the meaning of this paragraph have been established, they shall be taken into account by the Member States when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to.
在本段所指的欧共体草药专论建立后，成员国在评估申请时，应充分考虑专论的意见。在欧共体草药专论建立之前，其他合适的专论、出版物或数据可作为参考。
When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the competent authority of the Member State concerned.
当共同体新草药专论建立后，注册持有人应考虑是否有必要对注册档案提出修改以符合这些专论。注册持有者应把任何修改意见，通报给有关成员国主管当局。
The herbal monographs shall be published.
植物专论将被建立。
4. The general provisions of Regulation (EEC) No 2309/93 relating to the Committee for Human Medicinal Products shall apply by analogy to the Committee for Herbal Medicinal Products.
共同体2309/93号指令中关于人用药品委员会的一般条款将同样适用于草药产品。
Article 16i
Before 30 April 2007, the Commission shall submit a report to the European Parliament and to the Council concerning the application of the provisions of this chapter. The report shall include an assessment on the possible extension of traditional-use registration to other categories of medicinal products.
在2007年4月30日之前， 欧委会应向欧洲议会和理事会提交一个有关本章条款应用的报告，其中包括将传统使用注册扩展到其它类药品可能性的评估报告。
Article 2
第2条
1. The Member States shall take the necessary measures to comply with this Directive by 30 October 2005. They shall forthwith inform the Commission thereof.
1. 成员国应采取必要的措施，在2005年10月30日前与本指令一致。他们应当立即就有关情况通知欧委会。
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
当成员国采取了上述措施，并正式公布时，应当将本指令作为一个参考资料或附有参考本指令的文献。参考的方式由成员国自己决定。
2. For the traditional herbal medicinal products as referred to in Article 1, which are already on the market on the entry into force of this Directive, the competent authorities shall apply the provisions of this Directive within seven years after its entry into force.
2. 对于本指令第1条所指的那些传统草药产品，如果在本指令生效之前已经上市销售，主管当局应当在本指令生效后7年内对这些产品按该指令的规定进行管理。
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
第3条
本指令自在《欧共体官方杂志》发表之日起生效。
Article 4
This Directive is addressed to the Member States.
本指令提交给成员国。
Done at Strasbourg, 31 March 2004.
本指令于2004年3月31日在斯特拉斯堡完成。
For the European Parliament
The President
P. COX
欧洲议会议长
For the Council
The President
D. ROCHE
理事会主席
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