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Section 9 The party responsible for placing on the market 1 Medicinal products that are placed on the market within the purview of the present Act shall bear the name or the company and the address of the pharmaceutical entrepreneur.
This shall not apply to medicinal products intended for use in a clinical trial on human subjects. Section 10 Labelling 1 Finished medicinal products that are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, and are not intended for clinical trials on human beings or exempted from the obligation to obtain a marketing authorisation, pursuant to Section 21 sub-section 2 number 1a, 1b or 6, may only be placed on the market within the purview of the present Act provided that the following information is displayed on the containers and, where used, on the outer packaging in easily legible and indelible characters, in easily comprehensible German and pursuant to the details referred to in Section 11a: In so far as the information pursuant to sentence 1 is also provided in another language, the information provided in that language shall be identical.
Furthermore, space should be provided to state the prescribed dose; this shall not apply to the containers and ampoules referred to in sub-section 8 sentence Week 6 nur 405 presentation and to medicinal products intended exclusively for use by members of the medical profession.
Medicinal products that are manufactured using a homeopathic manufacturing procedure and are authorised pursuant to Section 25, are to be additionally labelled so as to indicate their homeopathic nature. Additional information which is not stipulated by a regulation of the European Community or the European Union, or is already admissible pursuant to such a regulation, shall be permitted if it is linked to the use of the medicinal product, is important in providing health information to the patient and is not inconsistent with the information referred to in Section 11a.
The other information mentioned in sub-section 1 sentence 1 number 2 on the pharmaceutical form and the group of persons for which the medicinal product is intended does not have to be written in Braille; this shall also apply if this information is contained in the name of the medicinal product.
Sentence 1 shall not apply to medicinal products that: Sentence 1 shall apply accordingly to medicinal products exempted from registration pursuant to Section 38 sub-section 1 sentence 3; sub-section 1b shall not apply.
The information in sub-section 1 sentence 1 number 3 is replaced by the registration number abbreviated to 'Reg. Sentences 1 and 2 shall apply mutatis mutandis to medicinal products which are exempted from registration pursuant to Section 38 sub-section 1 sentence 3 or pursuant to Section 60 sub-section 1.
In the case of traditional herbal medicinal products for administration to animals, the registration number with the abbreviation 'Reg.
The information pursuant to sentence 1 numbers 13 and 14 only need to be given on the outer packaging where an outer packaging exists.
It shall not be necessary to state the name and firm of a parallel importer. In the case of containers with a nominal filling quantity of not more than ten millilitres and single-dose ampoules, the information specified in sub-sections 1, 2 to 5 need only be displayed on the outer packaging; the containers and the ampoules must, however, at least bear the information specified in sub-section 1 sentence 1 number 2 first half-sentence, numbers 4, 6, 7, 9 as well as pursuant to sub-sections 3 and 5 sentence 1 numbers 1, 3, 7, 9, 12 and 14; adequate abbreviations may be used.
Sentence 3 shall also apply to small containers other than those mentioned therein in so far as divergent requirements are placed on small containers in procedures pursuant to Section 25b.
In the case of autologous blood preparations, the information 'Nur zur Eigenbluttransfusion' Only for Autologous Blood Donation must be given as well and, in the case of autologous and directed blood preparations, also an indication of the recipient. In the case of autologous tissue preparations, the information 'Nur zur autologen Anwendung' Only for Autologous Use must also be provided and, in the case of autologous and targeted tissue preparations, an additional indication as to the recipient.
The company to be indicated under sub-section 1 number 1 may be abbreviated, provided that the firm is generally recognizable from the abbreviation.
Blister packaging shall bear the name, the batch identification and the information pursuant to sentence 2.
Sub-section 1b shall not apply. Section 11 Package leaflet 1 Finished medicinal products which are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and are intended neither for clinical trial nor residue testing, or are exempted from the obligation to obtain a marketing authorisation pursuant to Section 21 sub-section 2 numbers 1a,1b or 6, may only be placed on the market within the purview of the present Act with a package leaflet bearing the heading 'Gebrauchsinformation' Instructions for Use and containing, in the same order as below, in easily legible, readily comprehensible German and in conformity with the information referred to in Section 11a: Medicinal products for human use that are included on a list compiled pursuant to Article 23 of Regulation EC No.
Explanatory information on the terms listed in sentence 1 is admissible. In so far as information referred to in sentence 1 is also rendered on the package leaflet in another language, the information provided in this language shall be identical.
Sentence 1 shall not apply to medicinal products that do not require a marketing authorisation pursuant to Section 21 sub-section 2 number 1. Additional information, which is not stipulated by a regulation of the European Community or the European Union, or is already permissible pursuant to such a regulation, is permitted provided it relates to the use of the medicinal product, is important for the health education of patients and is not inconsistent with the information referred to in Section 11a.
The marketing authorisation holder is required to keep scientifically up-to-date the package leaflet which includes the conclusions of assessments and recommendations published on the European internet website set up pursuant to Article 26 of Regulation EC No.
Sentence 1 shall apply mutatis mutandis to medicinal products which are exempted from registration pursuant to Section 38 sub-section 1 sentence 3. In addition, the package leaflet should include the advice referred to in Section 10 sub-section 4a sentence 1 number 2.
Furthermore, in the case of spa-waters, the order stipulated in sub-section 1 is not compulsory. The date of the last revision of the package leaflet shall be stated.
In respect of medicated pre-mixes, indications for the correct manufacture of medicated feeding stuffs and information on the shelf life of the medicated feeding stuffs shall be included.
Additional information is permitted in so far as it relates to the use of the medicinal product, is important for the user or animal keeper and is not inconsistent with the information referred to in Section 11a. In the case of medicinal products for use in animals, which are included in the Register of Homeopathic Medicinal Products or which are exempted from the registration pursuant to Section 38 sub-section 1 sentence 3 or pursuant to Section 60 sub-section 1 sentences 1, 2 and 4 shall apply mutatis mutandis subject to the proviso that the information stipulated in Section 10 sub-section 4, with the exception of the batch identification, the expiry date and the indication stipulated for samples must be provided.
In the case of traditional herbal medicinal products for use in animals, a corresponding indication pointing to the use in animals pursuant to Section 10 sub-section 4a sentence 1 number 2 shall be given in addition to the indications pursuant to sub-section 3b sentence 1.
Should additional information be given on the package leaflet, it shall be clearly set out and well separated from the information specified in sub-sections 1 to 4. Sub-section 5 shall apply mutatis mutandis. Sub-section 6 sentence 1 shall apply mutatis mutandis.Gmail is email that's intuitive, efficient, and useful.
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Übersetzung durch den Sprachendienst des Bundesministeriums für Gesundheit. Translation provided by the Language Service of the Federal Ministry of Health.