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歐盟傳統植物藥(草藥)注冊程序指令
DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
歐洲議會和理事會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
對歐共體人用藥品2001/83/EC指令中關于傳統草藥產品部分的修訂

(中文由商務部科技司翻譯整理,僅供參考)

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),
歐盟歐洲議會和理事會
遵照歐共體條約,特別是其中的第95條,
遵照歐委會的提議
遵照經濟和社會委員會的意見
依照條約第251條項下規定的程序

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.

鑒于:
(1)2001/83/EC指令規定:欲獲得藥品市場準入的申請者,應提供詳細技術資料和文件,它們應包括產品的理化,生物或微生物、藥理、毒理和臨床試驗結果,以證明產品的質量、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)若申請者能利用發表的詳細的科學文獻,闡述藥品的單一成分或多個成分具有確切的醫療用途,且確認其療效以及具有可接受的安全水平,根據2001/83/EC指令的要求,可以不必提供臨床前或臨床研究結果。
(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)大量的藥品,盡管它們有很長的歷史,如果不能滿足具有肯定的醫療用途、確切的療效和可接受的安全性的要求,也得不到上市許可。為了保持這些藥品在市場上的流通,成員國已經頒布了不同的注冊程序和管理辦法。各成員國現有這些法規上的差別可能會阻礙共同體內這些藥品的貿易,并導致這些產品生產者間的歧視和不規則競爭,這也可能會對公眾健康保護產生影響,因為目前藥品的質量、安全和有效性不總能得到必要的保證。
(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)考慮到這些藥品的特殊性質,特別是具有悠久的應用歷史,對某些傳統藥品提供一個專門的、簡化注冊程序是必要的。然而,這種簡化程序僅僅適合于在2001/83/EC指令中不能獲得上市批準的藥品,特別是那些由于缺少足夠的科學文獻來證實其療效的確切性及其安全性達到可接受水平者。它同樣不適合根據2001/83/EC指令可以獲得市場準入或注冊的順勢療法藥品。

(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)具有悠久應用史的藥品,可以免做臨床試驗,因為基于長期應用和實踐而得出藥品的有效性似乎是有理的。依據藥品的傳統應用信息,在特定情況下使用證明它們不是有害的,其臨床前研究似乎是不必要的。然而,即便是悠久的傳統應用史也不能排除對產品安全性的擔心,因此主管當局有權要求提供所有必要的資料以評價其安全性。藥品質量方面的要求與傳統應用無關,因此有關藥品必要的理化、生物學和微生物學的試驗是不能缺少的。產品質量應符合歐洲藥典專論或成員國的藥典要求。
(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)由于有悠久歷史和長期應用的大量傳統藥品是以草藥物質為基礎的。所以,首先進行簡化注冊的范圍僅限于傳統草藥產品看來是合適的。
(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)簡化注冊只應接受在共同體內有長期臨床應用的草藥產品。那些共同體之外應用的產品,只有在共同體內已應用一段時間,才能考慮簡化注冊。如果在共同體內使用的時間有限,在使用共同體外的使用紀錄時,應注意紀錄的有效性和實用性。
(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)為了進一步便于某些傳統草藥產品注冊并加強協調,有可能建立一個共同體的草藥物質目錄,該目錄中的草藥物質要達到一定的標準,例如,具有足夠長的藥用歷史,從而在正常使用下似乎是無害的。

(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)考慮到草藥產品的特性,應根據理事會2309/93號文件在歐盟藥品審評中心(下文:簡稱藥審中心)內部設立一個草藥產品的專門委員會。該委員會應根據本指令承擔草藥產品的上市批準和注冊方面的工作。其任務主要是建立適用于草藥產品注冊和授權的共同體草藥專論。該委員會應由草藥產品領域的專家組成

(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)保證新委員會和藥審中心目前的人用藥品委員會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)為了促進成員國之間的一致性,成員國對于另一個成員國根據共同體草藥專論或是對于已被列在將建立的目錄中的物質、制劑或化合物而注冊的草藥應予認可。對于上述兩種情況之外的,成員國對于另一個成員國注冊決定應予考慮。

(12) This Directive allows non-medicinal herbal products, fulfilling the criteria of food legislation, to be regulated under food legislation in the Community.

(12)本指令允許符合食品法規的非藥用植物產品依據共同體的食品法規進行管理。

(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)歐盟委員會應給歐洲議會和理事會提交一個有關傳統草藥產品法規部分的申請報告,其中包括簡化注冊擴展到其它類藥品可能性的評估報告。

(14) It is therefore appropriate to amend Directive 2001/83/EC accordingly,

(14)因此,應適當修訂2001/83/CE指令。

HAVE ADOPTED THIS DIRECTIVE:

已經采納該指令:

Article 1
第1條

Directive 2001/83/EC is hereby amended as follows:

指令2001/83/EC修訂如下:

1. in Article 1 the following is added:

1、在第1條中加入:
‘29. Traditional herbal medicinal product:

a herbal medicinal product that fulfils the conditions laid down in Article 16a(1);

“29、傳統草藥產品
滿足了第16a(1)條規定條件的草藥產品;

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、草藥藥品
以一種或多種草藥物質、一種或多種草藥制劑、以及一種或多種草藥物質與一種或多種草藥制劑復方作為活性組份的任何一種藥用產品;

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、草藥物質:
所有未經加工的植物全株、片段或切制的植物、植物部位、藻類、真菌和苔蘚類,都可稱為草藥物質,它們通常是干燥狀態,但有時也是新鮮的。不經特殊處理的某些分泌物也可作為草藥物質。草藥物質依使用的植物部位來定義,植物名依照雙命名系統(屬,種,變種和命名人)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、草藥制劑:
由草藥物質制備而得到,制備方法如萃取、蒸餾、壓榨、分餾、純化、濃縮和發酵。這些草藥制劑包括粉碎或粉狀的草藥物質、酊劑、提取物、揮發油、壓榨汁和經加工的分泌物等。
2. The following chapter is inserted in Title III:
2、下述章節插入第III篇中

‘CHAPTER 2a
章節2a:
Specific provisions applicable to traditional herbal medicinal products

適用于傳統草藥產品的具體條款

Article 16a
第16a條
1. A simplified registration procedure (hereinafter “traditional-use registration”) is hereby established for herbal medicinal products which fulfil all of the following criteria:
1、完全滿足如下標準的草藥產品,適用簡化注冊程序(下稱“傳統應用注冊”)。
(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)它們有適合于傳統草藥產品的獨特適應癥,這些傳統草藥產品的組成和用途,被設計為不需從業醫師的診斷、處方或監督等干預下就能使用;
(b) they are exclusively for administration in accordance with a specified strength and posology;
(b) 它們有與特定作用強度和劑量相符的特定服用方法。
(c) they are an oral, external and/or inhalation preparation;
(c) 它們是口服、外用和/或吸入制劑。
(d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed;
(d) 已過第16c (1)(c)條規定的傳統應用期。
(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) 藥品的傳統應用資料是充分的,特別是產品被證明在指定的條件下使用是無害的,在長期使用和經驗的基礎上,其藥理作用或藥效似乎是有道理的。
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、盡管1(30)條中已做出規定,但是對于含有維生素或礦物質的草藥產品,如果有證據證明其安全性,而且如果維生素或礦物質對于植物活性成分具有特別重要的輔助作用,可以根據第一段的要求進行注冊。

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,如果主管當局判定某傳統草藥產品符合第6條上市許可標準或第14條注冊標準,則不適用本章的條款。
Article 16b
第16b條
1. The applicant and registration holder shall be established in the Community.
1、申請者和注冊持有者必須在共同體范圍內。
2.In order to obtain traditional-use registration, the applicant shall submit an application to the competent authority of the Member State concerned.
2、為了獲得傳統應用注冊,申請者必須向有關成員國主管當局提交申請。
Article 16c
第16c條
1. The application shall be accompanied by:
1、申請應附有下列資料:
(a) the particulars and documents:
(a)相關詳細資料和文件
(i) referred to in Article 8(3)(a) to (h), (j) and (k);
(i) 遵照第8條(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條(3) (i)第二段的藥學試驗結果
(iii) the summary of product characteristics, without the data specified in Article 11(4);
(iii) 產品特性概要,不含第11條(4)中規定的詳細數據。
(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)對于第1條(30)或第16條a(2)中所論述的草藥復方,應提供第16條a (e)中對復方所要求的信息資料。如果該復方中單味藥的活性成分尚不完全清楚,這些信息資料也需要與單味藥的活性成分相關聯。
(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)申請者為將藥品投放市場在另一成員國或成員國以外的第三國獲得的市場準入批準或注冊批準[證件],以及有關拒絕給予市場準入批準或注冊批準決定的詳細資料(無論是成員國或成員國以外的第三國)和作出該決定的理由。

(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) 待批藥品或同類相關藥品功效的文獻或專家證據。它們是指在申請日之前已有至少30年的藥用歷史,包括在共同體內至少15年的使用歷史。成員國接到傳統使用注冊的申請后,在成員國的要求下,草藥產品委員會應對于該產品或相關產品長期應用的證明是否充分提出意見。成員國應提交相關文件。

(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) 安全性數據的文獻綜述和專家報告,以及主管當局額外要求的用以評價藥品安全性的必需材料。
Annex I shall apply by analogy to the particulars and documents specified in point (a).

附件一同樣適用于(a)中規定的資料和文件。

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)中所指的同類相關產品是指具有相同的活性成分(不考慮所使用的賦形劑)、相同或相似的治療目的、相同作用強度和劑量以及相同或相似的給藥途徑。
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、即使是沒有經過特定許可而在市場流通的產品,也符合第1段(c)中提及的已有30年的藥用歷史的要求。在該應用期間即使產品中組分的數目或劑量已有減少,同樣也符合要求。

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、如果產品在共同體內應用不足15年,但滿足其他申請簡易注冊的要求,接受傳統應用注冊申請的成員國,應將產品提交草藥產品委員會,并提交相關文件。
委員會應評估第16條a所提及有關簡化注冊的其它條件是否符合。如果委員會認為可能,將針對該產品起草一個共同體草藥專論(第16條h(3)所提及的),成員國應在做出最終決定時,充分考慮該專論的意見。
Article 16d
第16d條
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、在不違反第16條h(1)的情況下,第三部第4章可同樣適用于根據第16條a給予的注冊,如果:
(a) a Community herbal monograph has been established in accordance with Article 16h(3), or

已根據16條h(3)建立草藥專論

(b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.

草藥產品包含的草藥物質、制劑或混合物在16條f的目錄中

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.

對于第16條a中所提到的草藥產品,成員國在評估傳統使用注冊的申請時,應根據這一節充分考慮其他成員國已給予的注冊。

Article 16e
第16e條
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、如果申請與第16a,16 b或16c條不符,或是屬于下述情況的任何一種,該傳統應用注冊將被拒絕。
(a) the qualitative and/or quantitative composition is not as declared;
(a) 定性和/或定量組成與聲明中不符者;
(b) the indications do not comply with the conditions laid down in Article 16a;
(b)適應癥不符合第16 a條規定條件者;
(c) the product could be harmful under normal conditions of use;
(c) 產品在正常條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) 傳統應用資料不充分,特別是根據長期應用和經驗來判斷,其藥理作用或療效不確切者;
(e) the pharmaceutical quality is not satisfactorily demonstrated.
(e) 藥品的質量沒有獲得令人滿意的證明者。
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、成員國主管當局必須通知申請人、歐委會和任何提出要求的主管當局它拒絕傳統使用注冊的任何決定及拒絕的原因。
Article 16f
第16f條
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.應根據121條(2)中規定的程序建立一個在傳統草藥產品中使用的草藥物質、制劑和混合物的目錄。該目錄應包含每個草藥物質的適應癥,指定的作用強度和劑量,給藥途徑和任何其他與草藥物質的安全使用有關的必要信息。
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. 如果申請傳統應用注冊的草藥物質、制劑或混合物如第1段中提及的在目錄中,就可以不提供第16c (1) (b) (c) 和(d) 條所指定的資料。第16e (1) (c) 和 (d)條 將不適用上述情況。

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. 如果某種草藥物質、制劑或混合物從目錄(第1段中提及的)中被刪除,依照第2段注冊的、含有該物質的草藥藥品將被取消資格,除非按照第16c (1)條的要求,在三個月內提交相關的詳細資料和文件。

Article 16g
第16g條
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、以此類推,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條第二小段, 127條,以及共同體委員會的91/356/EEC指令 11適用于根據本章節所進行的傳統應用注冊。
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條的規定外,任何標簽和用戶包裝說明書應包含一個功效的聲明:
(a) the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and
(a) 本產品是僅基于長期使用適用于某適應癥的傳統草藥產品, 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)在藥品的使用過程中,如若癥狀持續,或出現說明書中未提及的副作用,使用者應當咨詢醫生或稱職的開業醫生。
A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question.
成員國應當規定:在標簽和用戶包裝說明書中,也應聲明該藥品所涉及的使用歷史。
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條的要求外,按本章節規定所注冊的任何藥品的廣告應包含如下聲明:“傳統草藥產品適用于某適應癥僅基于長期使用”。
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:

草藥產品委員會據此成立。該委員會是藥審中心的一部分并具有如下職能:
(a) as regards simplified registrations, t
(a)關于簡易注冊:
— perform the tasks arising from Article 16c(1) and (4),
履行第16條c(1)和(4)規定的職能
— perform the tasks arising from Article 16d,
履行第16條d規定的職能
— prepare a draft list of herbal substances, preparations and combinations thereof, as referred to in Article 16f(1), and
遵照第16條f(1)起草草藥物質、制劑和混合物的目錄草案
— establish Community monographs for traditional herbal medicinal products, as referred to in paragraph 3 of this Article;
遵照本條第三段起草建立共同體傳統草藥產品專論
(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)關于傳統草藥產品的認可,遵照本條第三段起草建立共同體傳統草藥產品專論
(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)關于依據第三部第四章向藥審中心提交的與第16條a規定的草藥產品相關的產品,履行第32條的職責
(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藥品依據第三部分第4章提交給藥審中心時,草藥產品委員會應適當地就其草藥成分提出意見。
Finally, the Committee for Herbal Medicinal Products shall perform any other task conferred upon it by Community law.
最后,草藥產品委員會還應履行共同體法律賦予其的其他職責。
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.
藥審中心的執行主任應根據2309/93法規的第55(2)條制定程序,確保(草藥產品委員會)與人用藥品委員會之間的適當合作。
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.每個成員國應向草藥產品委員會任命一名成員和一名替補成員,任期3年,可連任。
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.
替補成員在成員缺席的情況下代表成員投票。成員和替補成員的選擇應根據他們在草藥產品評價方面的職責和經驗,并代表國家主管當局。
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.
草藥產品委員會可以根據個人在所在領域的專長指派最多5名附加成員,任期3年,可連任,但不許替補。
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.
在指派上述成員時,草藥產品委員會應注意成員個人在所在領域的專長,指派成員可從成員國和藥審中心提名的專家中選擇。
The members of the said Committee may be accompanied by experts in specific scientific or technical fields.
草藥產品委員會成員可以包括特定科學或技術領域的專家
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. 草藥產品委員會應建立歐共體關于第[10a] [10(1)(a)(ii)]條申請的草藥產品和傳統草藥產品專論。委員會應履行根據本章條款的規定和其他共同體的法律所授予它的職責。
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.

在本段所指的歐共體草藥專論建立后,成員國在評估申請時,應充分考慮專論的意見。在歐共體草藥專論建立之前,其他合適的專論、出版物或數據可作為參考。

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.
當共同體新草藥專論建立后,注冊持有人應考慮是否有必要對注冊檔案提出修改以符合這些專論。注冊持有者應把任何修改意見,通報給有關成員國主管當局。
The herbal monographs shall be published.

植物專論將被建立。

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.

共同體2309/93號指令中關于人用藥品委員會的一般條款將同樣適用于草藥產品。

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, 歐委會應向歐洲議會和理事會提交一個有關本章條款應用的報告,其中包括將傳統使用注冊擴展到其它類藥品可能性的評估報告。

Article 2

第2條
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. 成員國應采取必要的措施,在2005年10月30日前與本指令一致。他們應當立即就有關情況通知歐委會。
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.

當成員國采取了上述措施,并正式公布時,應當將本指令作為一個參考資料或附有參考本指令的文獻。參考的方式由成員國自己決定。

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. 對于本指令第1條所指的那些傳統草藥產品,如果在本指令生效之前已經上市銷售,主管當局應當在本指令生效后7年內對這些產品按該指令的規定進行管理。


Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

第3條
本指令自在《歐共體官方雜志》發表之日起生效。

Article 4

This Directive is addressed to the Member States.
本指令提交給成員國。

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

歐洲議會議長

For the Council
The President
D. ROCHE

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