Cabinet of Ministers Regulations No. 7 in 2013 (January 3. No 1 26) amendments to the Cabinet of Ministers of 18 July 2006, regulations No. 600 "registration procedures for veterinary medicinal products" Issued in accordance with article 5 of the law on Pharmacy 3 and 6 points to make the Cabinet on 18 July 2006, regulations No. 600 "registration procedures for veterinary medicinal products" (Latvian journal, 2006, 127 no; 2007, nr. 161; 2009, 155.200. no; 2010, 185. No; 3, 2011 75 no) the following amendments: 1. provisions be supplemented by 7.1 points in this version : "7.1 veterinary medicinal products intended for use of equidae in accordance with the European Commission 6 June 2008 of Regulation (EC) no 504/2008 implementing Council Directive 90/426/EEC and 90/427/EEC with regard to the identification of equidae, article 20 is declared that it is not intended for use as food, you can register without stating the composition of the medicinal product concerned substances maximum residue levels in foodstuffs of animal origin in accordance with Regulation No. 37/2010." 2. Add to paragraph 9, after the words "(hereinafter registration application)" with a number and the word "(1.1)". 3. Delete paragraph 10. 4. Delete paragraph 13, the words and the number "10. these rules above". 5. Delete the 44, 49, paragraph 61, 71.1, 73.1 in and 84, the number "10". 6. To supplement the provisions of the annex, with 1.1 as follows: "annex 1.1 Cabinet of 18 July 2006, regulations no 600 application for registration of veterinary medicinal products (in the form of the European Commission) the summary of the Summary of the dossier administrative data administrative data of the Application Form: application form for use, by the food and veterinary service of the application for registration of veterinary medicinal products in the national, mutual recognition or decentralised procedure. Submit a separate application for each its strength and pharmaceutical form. (The application form is to be used for an application for a marketing authorisation of a medicinal product for veterinary use submitted to a Food and Veterinary Service under either (a) the mutual recognition procedure, national or decentralised procedure.
Usually a separate application form for each strength and pharmaceutical form is required.)
Declaration and signature DECLARATION and signature of the veterinary medicinal product (invented) name/product (invented) name: strength (s)/Strength (s): pharmaceutical form/Pharmaceutical form: active substance (s)/Active substance (s): the applicant/applicant: a Person authorized to represent the applicant/authorised Person for communications, on behalf of the applicant shall certify that the information supplied is sufficient to prove to be the quality, safety and efficacy of the veterinary medicinal product/It is hereby confirmed that all existing data on that with relevant to the quality , safety and efficacy of the veterinary medicinal product have been supplied in the dossier, as appropriate. Confirm that the registration of veterinary medicinal products in accordance with the costs of food and veterinary service paid list price **/It is hereby confirmed that fees have been paid according to the national rules. Representing the applicant/On behalf of the applicant: ____ ____ ____ ____ ____ ____ __ (signature/signature) ____ ____ ____ ____ ____ ____ ____ (name, surname/name) ____ ____ ____ ____ ____ ____ ____ (position/function) _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ (place/place) (date: yyyy-mm-dd/date (yyyy-mm-dd)) the application prescribed in paragraph 5.4 in the applicant's letter of authorization to add/attach letter of authorisation please for signing on behalf of the communications/the applicant in annex 5.4. ** The application prescribed in paragraph 5.1 of annex to add supporting documents/payment If fees have been paid, attach proof of payment in Annex 5.1.

1. veidsTyp application of application (complete only the sections/the following section should be completed where appropriate) 1.1 submission for registration of veterinary medicinal products/this application concerns 1.1.1. the mutual recognition procedure (Cabinet of 18 July 2006, rule no. 600 "registration procedure of veterinary medicines" (hereinafter Regulation No 600) 73)/A mutual recognition procedure (according to article 32 (2) of Directive 2001/82/EC transposed in article 73 of the Regulation of the Cabinet. "procedures for the 600 Registration of Veterinary Medicinal products" adopted on 18 July 2006 (Regulation No. 600)) the reference Member State shall (1)/Reference Member State registration date (yyyy-mm-dd) date of authorisation (yyyy-mm-dd) number of the registration certificate (copy of the registration certificate shall be presented, see application 4.2)/Marketing authorisation number (a copy of the authorisation should be provided – see section 4.2) procedure number/procedure number First submission/first use ▪ participating Member State (s) concerned (mark with X)/Concerned member State (s) (specify) AT BE BG CY CZ DE DK EE EL ES FI FR HU IE IS IT   LI LT LU LV MT NL PL PT RO SE SI SK FROM UK the common renewal date/Proposed Common Renewal date: If you submit messages or periodic security report Appendix cycle to align the origin of the substance, please specify If a waiver or amendment/of PSUR-cycle is applied for, a substance the harmonis with birthdate, please specify: first re submission (complete application 4.2)/repeat use 1st wave (Please also complete section 4.2) ▪ a participating Member State (s) concerned (mark with X)/ Concerned member State (s) (specify): the Following procedures to copy the table that follows For subsequent procedures,/copy the boxes BE BG CY CZ above AT DE DK EE EL ES FI FR HU IE IT LT LU LV MT ISA, LI NL NO PL PT RO SE SI SK UK the total Agreed re-registration date/Agreed Common Renewal date: 1.1.2. Decentralised procedure (rule no. 600 73)/A decentralised procedure (according to article 32 (3) of Directive 2001/82/EC transposed in article 73 of Regulation No. 600) references (1)/Reference Member State Member State procedures number/procedure number ▪ a participating Member State (s) concerned (mark with X)/Concerned member State (s) (specify): AT BE BG CY CZ DE DK EE EL ES FI FR HU IE IT LT LU LV MT ISA, LI NL NO PL PT RO SE SI SK UK if you submit messages or periodic security report Appendix cycle to harmonise the origin of the substance, please specify If a waiver or amendment/of PSUR-cycle is applied for, a substance the harmonis with birthdate, please specify: 1.1.3. National procedure national procedure the Member State//Member State the number of the Application, if available/If available, application number If submitting news or addition periodic security report cycle, to harmonise the origin of the substance, please specify If a waiver or amendment/of PSUR-cycle is applied for harmonis with it a substance, please specify the BirthDate: date (yyyy-mm-dd)/Date 1.2. the application is for registration of extension? (2)/Is this an application for a change to your existing marketing authorisation leading to an extension? (2) changes to match the expansion of the registration in accordance with the Commission on 24 November 2008, Regulation (EC) No 1234/2008 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products for conditions (hereinafter Regulation (EC) No 1234/2008) or Annex 1 of Regulation No 600 annex 6/Is this an application for a change to existing marketing authorisation leading to an extension as referred to in Annex 1 of Regulation (EC) 1234/2008 , or any national legislation, where applicable?
No (complete application 1.3 and 1.4) from (complete sections 1.3 and 1.4) Yes (fill out the application below and 1.4 points)/Yes (complete the section below and also complete section 1.4) specify the appropriate/please specify: changes in the bioavailability/change of bioavailability changes in pharmacokinetics/change of strength of pharmacokinetic changes or add new strength/change or addition of a new pharmaceutical form, strength or add a new pharmaceutical form/change or addition of a new pharmaceutical form of change or add a new type/ change or addition of a new route of administration of the qualitative changes to the declared active substance that is not defined as a new active substance (3)/qualitative change in declared active substance not defined as a new active substance (3) ○ substitution with other salt or ester, or derivatives thereof (the same healing effect)/replacement by a different salt/ester complex/counterparties, (the same therapeutic moiety) ○ substitution with other isomers , isomers, mixtures of isomers of isolated/replacement by a different isomer, isomer, mixtur of of a mixtur by an isolated isomer ○ replacing substances of biological origin or biotechnology products/replacement of a biological substance or product of biotechnology ○ other changes, specify/others (specify): change the productive exchange of target species of animals or add/change or addition of a food-producing animal species target notes. (1) the reference Member State shall mean the Member State, which shall draw up an assessment report on the veterinary medicinal product. (2) the applicant is the same as that applicable for the registration certificate. (3) the new active substance is a chemical or biological active substances which fulfil the following conditions: 1) the substance has not been previously registered in the composition of the veterinary medicinal product in the European Union; 2) active substances listed in the European Union, the composition of the veterinary medicinal product, the different salts, esters, ethers, isomers, mixtures of isomers of the potion, or derivatives with different characteristics with regard to the active substance safety and efficacy in comparison with the active substance established; 3) biological substances, previously registered as veterinary medicinal products in the European Union, but with a different molecular structure, raw materials or production processes/notes. (2) the applicant of the present application must be the same as the marketing authorisation holder of the existing marketing authorisation; (3) see definition in the notice to applicants, volume 1, Chapter 6A Of the existing registration certificate indicates the applicant For marketing authorisation in existing/the Member State where the application is made the owner of the registration certificate (holder)/name of the marketing authorisation holder name of the veterinary medicinal product, the strength, the pharmaceutical form/name, strength, pharmaceutical form of the existing product registration certificate (s) number (s)/Marketing authorisation number (s) of This application is 1.3 filed under the corresponding provisions of no 600 point/this application is submitted in accordanc with the following article of Directive 2001/82/EC transposed in Regulation No. 600: fill in each application, and submitted in accordance with section 1.2 of this annex/Sections to be completed for any application, including applications referred to in Section 1.2 (For further details, consult the notice to applicants, volume 6A, Chapter 1). 1.3.1. Regulation No. 600 12, 13 and 17 – full application (i.e. details of administration, quality, safety and efficacy data)/Article 12 (3) of Directive 2001/82/EC transposed in article 17 of Regulation 12, 13, Of. 600 – applications, (i.e. any other. dossier with administrative, quality, safety and efficacy data) the expanding application of cross reference may be provided for only pirmsiedarbīgum and efficacy data/For extensions of complete applications, cross reference can only be made to pre-efficacy and efficacy data of the new active substance a new active substance/(constituting the medicinal substances have not yet been registered by the competent authority/mobility scooters of a product not yet authorised by a competent authority) known active substance/known active substance (veterinary medicinal products, active substances constituting the already registered the competent authority or the European Medicines Agency-the same or other holder of the registration certificate/mobility scooters of a product already authorised by a competent authority or the Community – same or different marketing authorisation holder) 1.3.2. Regulation No 600 18, 19, 20 and 21 – application for registration of generic veterinary medicinal product/article 13 (1) of Directive 2001/82/EC (transposed in article 18, 19, 20 and 21 of Regulation No. 600)-the Generic application of generic application for registration of veterinary medicinal products as defined in rule no. 600, according to point 2.2. making reference to the so-called reference veterinary medicinal products that have been registered with the European economic area or the European Medicines Agency has issued a certificate of registration/Application for a generic veterinary medicinal product as defined in article 13 (2) (b) of Directive 2001/82/EC (transposed in the article 2 (2) of Regulation No. 600) referring to a so-called reference veterinary medicinal product with a Marketing authorisation granted in a Member State or in the Community to prepare a complete administrative and quality data, appropriate safety and efficacy data, if required (subject to the provisions of no. 600 37.1. referred to in the recommendations of the European Community, published by the European Community pharmaceutical legislative framework document item (hereinafter referred to as the ATC) volume 6, part A, section 1)/complete administrative and quality data, appropriate safety and efficacy data when applicable (see Chapter 1 of the notice to applicants, volume 6A) shall. Reference veterinary medicinal products which have been registered or was registered in the European economic area not less than 6 to 10 years/reference veterinary medicinal product which is or has been authorised for not less than 6/10 years in the EEA: the name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder first registration-date (yyyy-mm-dd)/First authorisation – date : European economic area country name, or a European Union Member State (EEA)/Community 1.3.2.2. Reference veterinary medicinal products registered in the European Union or the Member State in which the application is filed/veterinary medicinal product authorised for reference in the Community/Member State where the application is made, the name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder of the registration certificate number/Marketing authorisation number (s) 1.3.2.3. Veterinary medicinal products used in the bioequivalence studies (if necessary)/Veterinary medicinal product used for bioequivalenc study (where applicable) name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder in the Member State of origin/Member State of source 1.3.3. Regulation No 22-600 reference is made of the so-called reference veterinary medicinal products, which are members of the European economic area or the competent authority of the country of the European Medicines Agency issued a registration certificate and which have a different pharmaceutical form therapeutic use, etc. (the so-called hibrīdiesniegum)/article 13 (3) of Directive 2001/82/EC (transposed in the article 22 of Regulation No. 600)-the so called "hybrid applications". Application for a veterinary medicinal product referring to the so-called reference veterinary medicinal product with a Marketing Authorisation in a Member State or in the Community (e.g. different pharmaceutical form, different therapeutic use ...)
Prepare administrative and quality data, appropriate safety and efficacy data, if necessary, in accordance with the NTA (A) 6 volume 1 section/complete administrative and quality data, appropriate safety and efficacy data refer to notice to applicants, volume 1, Chapter 6A 1.3.3.1. Reference veterinary medicinal products which have been registered or was registered in the European economic area not less than 6 to 10 years/reference veterinary medicinal product which is or has been authorised for not less than 6/10 years in the EE name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder first registration-date (yyyy-mm-dd) date/First authorisation – European economic area country or the European Union/Member State (EEA)/Community 1.3.3.2. Reference veterinary medicinal products registered in the European Union/Member State in which the application is filed/veterinary medicinal product authorised for reference in the Community/Member State where the application is made, the name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder of the registration certificate number/Marketing authorisation number (s) of the 1.3.3.3. Veterinary medicinal products used in the bioequivalence studies (if necessary)/Veterinary medicinal product used for bioequivalenc study (where applicable) name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder in the Member State of origin/Member State of source of the Difference (s) in comparison with the reference veterinary medicinal products/difference (s) compared to the reference veterinary medicinal product: active substance (s) changes/changes in the active substance (s), therapeutic indications of changes in the therapeutic indication of change/pharmaceutical form changes change in pharmaceutical form/strength changes (active substances quantitative changes)/change in strength (quantitativ change to the active substance (s)) use the change/change in route of administration cannot prove bioequivalence bioavailability studies/bioequivalenc cannot be demonstrated through bioavailability of studies 1.3.4. Regulation No 23-600 application for similar biological veterinary medicinal product/article 13 (4) of Directive 2001/82/EC (transposed in the article 23 of Regulation From. 600) – Similar biological applications in the application of the veterinary medicinal product is made reference to reference biological veterinary medicinal products/Applications for a product referring to a reference biological product.
Administrative, quality, appropriate safety and efficacy data to design according to the NT. (A) the volume 6, part 1/the complete administrative and quality data, appropriate safety and efficacy data refer to notice to applicants, volume 6A, Chapter 1.
1.3.4.1. Reference veterinary medicinal products which have been registered or was registered in the European economic area not less than 6 to 10 years/reference veterinary medicinal product which is or has been authorised for not less than 6/10 years in the EE name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder first registration-date (yyyy-mm-dd) date/First authorisation – European economic area country or the European Union/Member State (EEA)/Community :   1.3.4.2. Reference veterinary medicinal products established in the Member State in which the application is filed/veterinary medicinal product authorised for reference in the Member State where the application is made, the name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder of the registration certificate number/Marketing authorisation number (s) 1.3.4.3. Veterinary medicinal products used in the bioequivalence studies (if necessary)/Veterinary medicinal product used for bioequivalenc study (where applicable) name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder in the Member State of origin/Member State of source 1.3.5. Regulation No 28 600-using the well-established veterinary practice/article 13 of Directive 2001/82/EC (transposed in article 28 of Regulation No. 600)-Well established veterinary use.
Bibliographic submission cross-referenced enlargement can only be about pirmsiedarbīgum and efficacy data/For extensions of bibliographical applications, cross reference can only be made to pre-efficacy and efficacy data.
Shall be drawn up in accordance with Regulation No. 600 and NT volume 6, part A, section 1/For further details, consult the notice to applicants, volume 1, Chapter 6A. 1.3.6. Regulation No 31-600 combined veterinary medicinal product/article 13b of Directive 2001/82/EC (transposed in article 31 of Regulation No. 600)-Fixed combination administrative quality, pirmsiedarbīgum and efficacy data only combinations/complete administrative and complete quality , pre-efficacy and the efficacy data on the combination only.
Expanding the application relating to the fixed combinations of mutual reference only on pirmsiedarbīgum and efficacy data/For extensions of fixed combination applications, cross reference can only be made to pre-efficacy and efficacy data. 1.3.7. Regulation No. 33-600 application with informed consent/article 13 c of Directive 2001/82/EC (transposed in article 33 of Regulation No. 600) – Informed consent application an application for the registration of veterinary medicinal products, which the qualitative and quantitative composition in active substances and pharmaceutical form is identical to the already registered veterinary medicinal products and veterinary medicinal products registered in the registration certificate to the owner of the application, the applicant is allowed to use the data specified in the registration of veterinary medicinal products registered in the documentation for the/Application for a veterinary medicinal product possessing the same and composition of quantitativ qualitativ in terms of the active substances and the same pharmaceutical form of an authorised product where consent has been given by the marketing authorisation holder existing to use their data in support of this application.
Submit complete administrative data with permission (consent) use pharmaceuticals, pirmsiedarbīgum and efficacy data/complete administrative data should be provided with the consent of their pharmaceuticals, pre-efficacy and efficacy data.
The veterinary medicinal product, the holder of the registration certificate (the owner), and the applicant may be the same or a different person/the product an informed consent and the application can have the same or different MAH.
1.3.7.1. Veterinary medicinal products which are authorised in the European Union or the Member State in which the application is filed/product in the Authorised Community or Member State where the application is made, the name, strength, pharmaceutical form/product name, strength, pharmaceutical form of the registration certificate holder/Marketing authorisation holder of the registration certificate number/Marketing authorisation number (s) of application prescribed in paragraph 5.2 of annex added to the veterinary medicinal products concerned on the registration certificate holder's consent letter/letter of consent to Attach from the marketing authorisation holder of the authorised product (Annex 5.2) 1.3.8. Regulation No 600 34. point-application on the immunological veterinary medicinal products which have not been submitted separate studies/article 13d of Directive 2001/82/EC (transposed in article 34 of Regulation No. 600), Immunological Veterinary Medicinal product for which the results of certain trials not being submitted. 1.4. information on maximum residue levels (MRLs) (only food-producing animal species)/MRL status (only for food producing species) in the case of veterinary medicinal products intended for food-producing animals, please indicate the following information available to the application in time (1)/When the medicinal product is intended for veterinary use in food-producing animals, please provide the following information as available at the time of submission of the application (1).
The maximum residue level in accordance with European Parliament and Council Regulation (EC) no 407/2009 (2) and Commission Regulation (EU) No 37/2009 (3) is published in the official journal of the European Communities (OJ)/maximum Residu limits (MRLs) according to Regulation (EC) of the 470/2009 of the European Parliament and of the Council and Commission Regulation (EU) From 37/2010 has been published in the Official Journal of the European communities : substance (s)/substance (s) Annex/Annexe species/species/target target tissue tissue (s) notes/Remarque publications date O.J./OJO date of publication notes.
(1) all substances contained in veterinary medicinal products is subject to this condition, if the substance is pharmacologically active dose, administered to the animal. Adjuvants, which are not included in Regulation (EC) No 37/2010 respectively should be accounted for and justify their use. (2) the European Parliament and of the Council on 9 May 2009. Regulation (EC) no 470/2009 laying down Community procedures in the field of residues of pharmacologically active substances to levels in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending European Parliament and Council Directive 2001/82/EC of the European Parliament and of the Council Regulation (EC) No 726/2004 (3) the Commission of 22 December 2009 Regulation (EU) No 37/2009 on pharmacologically active substances and their classification according to their maximum allowable content. The notes.
(1) All substances in the product led to the subject to this requirement if they are pharmacologically active in the dose in which they are administered to the animals. Excipient not included in the Annex of Commission Regulation (EU) From 37/2010 should also be listed and an appropriate justification given. 1.5. details of application, submitted in accordance with the following rules of no 600 dots/Considerations of this application is also requested under the following article: 1.5.1. Regulation No 600 57 (in exceptional cases)/Exceptional Circumstanc (article 26 (3) of Directive 2001/82/EC, transposed in article 57 of Regulation No. 600) 1.5.2. accelerated review/review note: the accelerated centralised procedure only according to Regulation (EC) No. 726/2004 article 39 (8) date of acceptance by the CVMP: 1.5.3. Regulation No 600 paragraph 24 (adding a new species of food-producing animals for five years after the initial registration, in addition to the one-year data protection)/article 13 (5) of Directive 2001/82/EC, transposed in article 24 of Regulation No. 600 (one year of data exclusivity for an extension to another food-producing species within five years of the initial authorisation) application for registration 2 detailed information Marketing authorisation application in the particular name and 2.1 farmakoterapeitisk Group (ATC vet code)/Name (s) and the ATC vet code 2.1.1. veterinary medicinal products the name given in the European Union/Member State of the European Union/Iceland/Liechtenstein/Norway/Proposed (invented) name of the veterinary medicinal product in the Community/Member State/Iceland/Lichtenstein/Norway if the mutual-recognition procedure or the decentralizētāj it is reported about the different names in the different Member States, the names of the list and add the application to the list in the annex/5.18 If different (invented) name in different Member States are proposed in a mutual recognition or decentralised procedure, these should be listed in Annexe 5.18 2.1.2. the name of the active substance (s) of the active/name substance (s) Note. One name in the following priority order: INN (international non-proprietary name), the European Pharmacopoeia, the General name, scientific name. Active substance to declare, indicating the recommended INN with active substance salt or hydrate form if necessary (for more information about the summary of the guidelines). Note. Only one name should be given in the following order of priority: INN, Ph Eur, National Pharmacopoei, common name, scientific name. The active substance should be declared by it in the recommended INN, accompanied by its salt or form if relevant hydrat (for further details, consult the guideline on the SPC).
2.1.3. farmakoterapeitisk Group (anatomical therapeutic chemical veterinary code (ATC vet code))/Pharmacotherapeutic group (please use current ATC vet code) ATC vet code/ATC vet code: Please indicate if ATC vet code application has not yet been approved/please indicates if the application for the ATC vet code is still pending group/Gp 2.1.4. target species/target species 2.2. Strength, pharmaceutical form, route of administration , type of packaging and packaging size/Strength, pharmaceutical form, route of administration, container and pack size of 2.2.1. strength and pharmaceutical form (use standard terminology in accordance with the European Pharmacopoeia)/Strength and Pharmaceutical form (use current list of standard terms-European Pharmacopoei) pharmaceutical form/Pharmaceutical form, active substance (s)/Active substance (s) strength (s)/Strength (s) 2.2.2. entry type (s) (use standard terminology in accordance with the European Pharmacopoeia)/Route (s) of administration (use the current list of standard terms-European Pharmacopoei) 2.2.3. the primary packaging , the sealing system and injection device (s), including packing material description (use standard terminology in accordance with the European Pharmacopoeia)/Container, closur and administration device (s), including description of material from which it is constructed (use current list of standard terms-European Pharmacopoei) for each packaging type to specify/For each type of pack give: 2.2.3.1. the package size (s)/Package size (s) of the note. Specify all the packing size of the reference country mutual recognition or decentralised procedure. Note. For mutual recognition and decentralised procedures, all package size of the authorised in the reference Member State should be listed. 2.2.3.2. the specific expiration date/shelf life proposed 2.2.3.3. the prescribed validity period (after the first opening of the container)/proposed shelf life (after first opening the container), 2.2.3.4. the period of validity specified (after preparation for use or after reconstitution)/proposed shelf life (after reconstitution or dilution) 2.2.3.5. specified storage conditions/proposed storage conditions 2.2.3.6. storage conditions laid down by the first open/proposed storage conditions after first opening trade package labels add a mock-up or sample application attached to the trade lists of the If necessary, the application prescribed in paragraph 5.17/Attach in the annex list of Mock-ups or Sample/specimen is sent with the application, as appropriate (see notice to applicants, volume 6A, Chapter 7) (5.17 Annexe). The notes. * A highlight mock-up (mock-up) is a label design using colors intended to indicate information that is intended to specify both the primary and secondary packaging, and featured a three-dimensional label text. To submit a paper copy or electronically created version. ** Marketing sample (Specimen) is the current primary and secondary packaging and instructions for use.
2.3. the distribution conditions/Legal status 2.3.1. instructions for use/proposed administration: you can enter only practicing veterinarian/veterinary surgeon by a may only enter the only practicing veterinarian or other person under the responsibility of the veterinary surgeon or a/by under their direct responsibility other/others: 2.3.2. proposal for classification/classification: proposed/dispensing veterinary medicinal product which is distributed to the recipe/subject to medical prescription of veterinary medicinal products distributed free recipes/not subject to medical prescription is subject to other controls (if any) of the other controls to specify/subject who/specify: 2.3.3. veterinary medicinal products which is distributed to the recipe/for veterinary products subject to medical prescription: veterinary medicines for veterinary prescription/veterinary product prescription veterinary medicines for one special veterinary prescription/veterinary product on special prescription veterinary drug with limited discharge/veterinary product on restricted prescription/use 2.3.4. veterinary medicinal products which is distributed without a prescription/supply for products not subject to medical prescription : distributed in pharmacies/supply through pharmac to only distribute only practicing veterinarian/supply/administration by veterinary surgeons only distributed by pharmacies and medical treatment of the animal by a veterinarian course completion/supply by pharmac and/or veterinary surgeons for animals under their care 2.3.5. the advertising of veterinary medicinal products, which are distributed without a prescription/promotions for products not subject to medical prescription: just for practicing veterinarians/promotion to health care professionals and the general public only for practicing veterinarians/promotion to the general public and health care professionals 2.4. the holder of the licence or Marketing authorisation holder/contact/contact person/Company 2.4.1. the holder of the registration certificate or the person legally responsible for placing the veterinary medicinal product on the market in each Member State, the Proposed marketing authorisation holder/person/legally responsible for placing the product on the market in the each MS: name (merchant business)/(Company) name address/address State/Country telephone number/fax number/telephone Telefax email address/E-Mail application specified in point 5.3 of the annex to add confirmation of the applicant's registration in the European economic area country/Attach proof of establishment of the applicant in the EEA (Annex 3.3) 2.4.2. The Person or economic operator authorised by the communication by the applicant Member State each/Person/company communications on behalf of the authorised for the applicant during the procedure in the each MS: name, surname/name if different from the application referred to in paragraph 2.4.1., add the application prescribed in paragraph 5.4 of the annex/If different it 2.4.1 above, attach letter of authorisation (Annex 5.4) name (merchant business)/(Company) name address/address State/Country telephone number/fax number/telephone Telefax e-mail address/E-Mail 2.4.3. The person or economic operator, by the holder of the registration certificate authorized for communication with the competent authority after the registration of veterinary medicinal products, if it differs from the application referred to in paragraph 2.4.2., in each Member State, the Person/Company/communications between authorised for the marketing authorisation holder and the competent authorities after the authorisation if different from 2.4.2 in the each MS: name, surname/name if different from the application referred to in paragraph 2.4.1. , add the application prescribed in paragraph 5.4 of the annex/If different it 2.4.1 above, attach letter of authorisation (Annex 5.4) name (merchant business)/(Company) name address/address State/Country telephone number/fax number/telephone Telefax email address/E-Mail 2.4.4. qualified person responsible for pharmacovigilance/Qualified person in the EEA for PharmacovigilanceVārd, surname/name: name (merchant business)/(Company) name address/address State/Country 24-hour telephone number/24 H telephone fax number/e-mail address Telefax/E-Mail resume (by the qualified person to add the application in paragraph 5.5. in the annex (see also submission referred to 5.20) C.V. of/Attach qualified person) (Annex 5.5). See also Annex – point 5.20 2.5. producers/manufacturers note. Identify all the production and control of documentation by giving their name, detailed address and specific steps in the production process. Note. All manufacturing and control sites mentioned throughout the whole dossier must be consistent regarding their names, detailed addresses and activities.
2.5.1. the registered manufacturer (or importer), responsible for the serial output of the European economic area in accordance with Regulation No 319 (1) (6) and indicate in the instructions for use and, if applicable, the label/manufacturer (s) of the Authorised (or importer) responsible for batch release in the EEA in accordanc with article 55 and article 53 of Directive 2001/82/EC transposed in the Regulation Of. 319 (1) (as shown in the package leaflet and where applicable in the labeling) name (merchant business)/(Company) name address/address State/Country telephone number/fax number/telephone Telefax email address/E-Mail ▪ special permission (license) manufacture of the veterinary medicinal product number/Manufacturing Authorisation number: ▪
special permissions (licenses) for the production of a copy of the veterinary medicinal product (add the application prescribed in paragraph 5.6. annex)/Attach copy of manufacturing authorisation (s) (Annex 5.6) ▪ rationale, if more than one producer is responsible for the serial output (add the application referred to in subparagraph annex 5.7)/Attach justification if more than one manufacturer responsible for batch release is proposed (Annex 5.7) Vaccines/For information on the vaccines laboratory, which are carried out under official control of series or series of official control protocol (rule no 407 (2) 13)/Details of the State laboratory ora laboratory designated for that purpose (OMCL) where the official batch protocol review (article 81 of Directive 2001/82/EC transposed in the title of Regulation No. 13, 407 (2)) or the official control authority batch release takes place. Name (Company) name/address/address State/Country telephone number/fax number/telephone Telefax email address/E-Mail notes. (1) the Cabinet of Ministers of 15 May 2007 No. 319 of the rules "rules for the manufacture of veterinary medicinal products and control the order in which the veterinary medicinal product, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements" (hereinafter Regulation No 319). (2) the Cabinet of Ministers on 19 June 2007, the provisions of no. 407 "the labelling of the veterinary medicinal product, distribution, and control rules". The notes. (1) Regulations of the Cabinet of Minister of 15 May 2007. 319 "Regulations Regarding the manufacture and Control of Veterinary Medicinal products, the procedure for the Issuance of a Good Manufacturing Practice certificate to a Manufacturer of Veterinary Medicinal products and Regarding the requirements for the Qualification and Professional experience of the Official Responsible for the manufacture of Veterinary Medicinal products" (Regulation No. 319); (2) Regulations of the Cabinet of Minister of 19 June 2007 From. 407 "Regulations Regarding the Labelling, Distribution and Control of Veterinary Medicinal products".   2.5.1.1. the contact person for communication about the faults of the veterinary medicinal product and a recall/contact person in the EEA for product defect and recall your name/address/address name State/Country 24-hour telephone number/24 H telephone fax/Telefax e-mail address/E-Mail 2.5.1.2. control and series testing data/Batch control/Testing arrangements in place, which is performed in the serial control (if different from the application referred to in paragraph 2.5.1.) in accordance with Regulation No. 319 (1)/Site (s) in the EEA or in countries where an MRI or other Community arrangements will apply where batch control/testing takes place (if different from 2.5.1) as required by article 55 of Directive 2001/82/EC transposed in the Regulation Of. 319 (1): name (Company) name/address/address State/Country telephone number/fax number/telephone Telefax email address/E-Mail a brief description of the control tests carried out on the question (s) (s) involved laboratory (s)/Brief description of control test carried out by the laboratory (-ies) concerned 2.5.2. Veterinary medicinal products, the manufacturer (s) and place (s)/Manufacturer (s) of the veterinary medicinal product and the site (s) of manufacture (also specify the place of manufacture that is prepared for any solutions, solvents, which added in a separate package, but is part of the veterinary medicinal product including manufacturing sites of any/diluen/solvent presented in a separate container but forming part of the veterinary medicinal product) name, surname/name/Name (Company) name address/address State/Country telephone number/fax number/telephone Telefax email address/E-Mail a brief description of the functions of the manufacturer of the dosage forms production , collection, etc./Brief description of functions performed by the manufacturer of the "forms/assembler, etc.: production flow map with a specified sequence of the individual production locations and events, and activities, including the production process control (add the application prescribed in paragraph 5.8 in)/Attach flow-chart indicating the sequence and activities of the different sites and activities involved in the manufacturing process, including testing sites (Annex 5.8) • if the production site is a European economic area country/If the manufacturing site is in the EEA : special permission (license) number of the manufacture of veterinary medicinal products/manufacturing authorisation number: special permit (license) for the manufacture of veterinary medicinal products (copy) (add the application prescribed in paragraph 5.6. annex) manufacturing authorisation required/attach under article 44 of Directive 2001/82/EC transposed in the Regulation Of. 319 (Annex 5.6) the qualified person's name (if not the production licence)/Name of qualified person (if not mentioned in the manufacturing authorization): • If the production site is outside the European economic area country/If the manufacturing site is outside the EEA where mutual recognition agreement or other European Union and national conditions of the Treaty, the document that is equivalent to the production license (add the application referred to in subparagraph annex 5.6)/Where or others subject to the MR Community apply to attach equivalent of manufacturing authorisation (Annex 5.6) Or place of production compliance with the good manufacturing practice (GMP) is inspicējus in the European economic area national competent authority or the competent authority of the State, which concluded a mutual recognition agreement or other conditions applied in accordance with European Union and national contract?/Has the site been inspected for GMP compliance by an authority or by an authority in the EEA of countries where Mutual Recognition agreements (MRA) or other Community arrangements will apply within the terms of the agreement? no/no yes/yes if the answer is "Yes", the application prescribed in paragraph 5.9. Annex to add information about each production location inspections results/If yes, please provide in Annex 3.7 for each site, a statement from the competent authority which carried out the inspection, including:-the last GMP inspection date/last date the GMP inspection-the name of the competent authority which carried out the inspection/name of competent authority which carried out the inspection the inspected product categories-and inspected activities/category of products and activities inspected-results/ outcomes: GMP compliance/GMP compliant: No/Yes/yes or from the place of production of the GMP compliance inspections carried out the competent authority of the State, which concluded a mutual recognition agreement or other conditions applied in accordance with European Union and national agreement, but the inspection was not carried out in the territory the site?/Has been inspected for GMP compliance by any other authority including those of countries where the subject of the MR or other Community apply but not within the territory of the respectiv? no/no yes/yes if the answer is "Yes", the application prescribed in paragraph 5.9. Add annex summarizes information/If yes, please provide the summary information in Annex 5.9 including/GMP inspection including:-last date/last date the GMP inspection-the name of the competent authority which carried out the inspection/name of competent authority which carried out the inspection the inspected product categories-and inspected activities/categories of products and activities/outcomes results is inspected- : positive/negative/positive negative 2.5.3. the manufacturer of the active substance (s) and place (s)/Manufacturer (s) of the active substance (s) and site (s) of manufacturePiezīm. Specify all the sites involved in the production process of the active substance. Intermediaries or suppliers alone is not acceptable. Biotechnology products indicate in which store the master and working cell bank and working cell bank products. The notes. All manufacturing sites involved in the manufacturing process of each source of active substance should be listed. Brokers or suppliers details alone are not acceptabl ... For biotech products include all sites of storage of master and working cell bank and working cell bank preparation of. Substance/substance: the name/address/address name State/Country telephone number/fax number/telephone Telefax email address/E-mail a brief description of the production phase of the production site/Brief description of manufacturing steps performed by manufacturing site submission 5.8. annex referred to add production flow map that indicates all the production process involved in the production sequence, and a series of measures, including the control/Attach flow-chart indicating the sequence and activities of the different sites involved in the manufacturing process , including batch control sites (Annex 5.8) for each active substance submission 5.19. the annex referred to in subparagraph add an application referred to in paragraph 2.5.1. a manufacturing authorization (license) of the owner (s) and application by the qualified person referred to in paragraph 2.5.2. a manufacturing authorization (license) of the owner (s) of the qualified person Declaration of the manufacturer of the active substance referred to in paragraph 2.5.3. application, in accordance with detailed the active substance, the principles of good manufacturing practice, if the active substance is used as a raw material for/For each active substance, attach a declaration from the Qualified Person of the manufacturing authorisation holder (s) in Section 2.5.1 and Qualified from the Person of the manufacturing authorisation holder (s) listed in Section 2.5.2 where the active substance is used as a starting material (Annexe 5.19) that the active substance manufacturer (s) referred to in Section 2.5.3 operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. • The active substance is the subject of the European Pharmacopoeia, a certificate of conformity/Has a Ph Eur. Certificate of suitability been issued for the active substance (s) from the yes/no/yes if yes yes:-substance/If/substance-the manufacturer's name/name of the manufacturer-reference number/reference number-the last renewal date (yyyy-mm-dd)/date of last update (yyyy-mm-dd): Add a copy of the application referred to in paragraph 5.10./in the annex provide copy in Annex 5.10 • Or use the master/active substance Is an active substance Master file (European Drug Master file) to be used for the active substance (s) of reference/original? no/no yes/yes if yes yes:-substance/If/substance-the manufacturer's name/name of the manufacturer-the competent authority or the European Medicines Agency reference number/reference number for AMA/competent authority-submission date (yyyy-mm-dd)/date of submissions (yyyy-mm-dd)-the last renewal date (yyyy-mm-dd)/date of last update (yyyy-mm-dd)-submission 5.10. annex referred to add access permissions for the active substance master file, addressed to the European Medicines Agency or the Member State in which application/attach letter of access for the Community/Member State authorities where the application is made (see European DMF procedure for active ingredients) (Annex 5.10)-5.11 of the application referred to in the annex to add active substance manufacturer's written confirmation that the applicant will be informed of the manufacturing process or specifications change/attach copy of written confirmation from the manufacturer of the active substance notified the applicant in case of modification of the manufacturing process or specifications according to Annex I of Directive 2001/82/EC transposed in the Annex1 and 2 of Regulation No. 600 (Annexe 5.11) 2.5.4. the economic operators that perform bioavailability or bioequivalence studies/contract companies used for bioavailability or bioequivalenc trials each merchant specifies which analysis tests and efficacy data collects and provides For each contract company/State where analytical test performed and where the data is collected and efficacy with the give name/name address/address State/Country telephone number/fax number/telephone Telefax email address/E-mail responsibilities carried out in accordance with the contract/Duty performed according to contract the original/reference name of the veterinary medicinal product and the country of origin and country of origin/name of the original/reference product 2.6. Qualitative and quantitative composition in terms of the composition of the Qualitativ and quantitativ/2.6.1. active substances and excipients in the qualitative and quantitative composition in terms of the composition of the Qualitativ and Quantitativ/in terms of the active substance (s) and the excipien (s) to identify the the components of the specified quantity of the product (for example, 1 capsule)/A note should be given as to which quantity the composition refer (e.g. 1 capsule) list of active substances (separate from the excipients)/list the active substance (s) separately from the excipien (s): active substance (s) title/name of the active substance (s) Quantity/Quantity Unit/unit reference/monograph standard/reference/Monograph standard, etc./etc.
Excipient (s) title/name of excipien (s) Quantity/Quantity Unit/unit reference/monograph standard/reference/Monograph standard, etc./etc. The notes. (1) for each substance only one name in the following order of priority: the World Health Organization (who) recommended international non-proprietary name (INN), European Pharmacopoeia, common name, scientific name. (2) the active substance must be declared with the recommended INN, with added salt or hydrate, if necessary (see the summary of the guidelines). The notes. (1) Only one name for each substance should be given in the following order of priority: INN, Ph Eur, National Pharmacopoei, common name, scientific name. (2) the active substance should be declared by it in the recommended INN, accompanied by its salt or form if relevant hydrat (for further details, consult the guideline on the SPC). Data on any excess units-not to include the substance in the table, but specify below details of any of the overag/should not be included in the formulation columns but stated below:-the active substance (s)/active substance (s):-excipient (s)/excipient (s) 2.6.2. substances of animal origin list that included veterinary medicinal products or veterinary medicinal products used in the production process/list of materials of animal origin used in the manufacturing or the led process of the veterinary medicinal product? No/NON name/name */Function function * material of animal origin susceptible to TSE **/Animal origins to TSE susceptibl ** Other materials of animal origin/Other animal origin TSEs conformity certificate number/certificate of suitability for TSE (State number) AV PV R 1.
2.
3.
4.
utt.             * AV-PV-active substances, excipients (including raw material used for the active substance or an excipient in the manufacture), R – reagent/environment (including the materials used in preparing or working cell bank)/S = active substance, EX = excipien (incl. starting materials used in the manufacture of the active substance/excipien), R = the reagen/culture medium (incl. those used in the preparation of the master cell bank UN working) * in accordance with the guidelines for the monitoring of transmissible spongiform encephalopathy (TSE) risk reduction defined in Chapter 2/As defined in section 2 (scope) of the note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. If compliance with European Pharmacopoeia certificate of TSE is available, it adds the application prescribed in paragraph 5.12./If (a) in the annex Ph. EUR. Certificate of Suitability for TSE is available according to Resolution AP/CSP (99) 4 of the Council of Europe attach it in Annex 5.12 Or veterinary medicinal products containing genetically modified organisms (GMO) or consisting of genetically modified organisms within the meaning of the law of circulation/Do the veterinary medicinal product contains Genetically Modified Organisms or consis of (GMO) within the meaning of Directive 2001/18/EC transposed in the Law on Circulation of Genetically Modified Organism? No/No Yes/Yes if the answer is "Yes", does the product meet the genetically modified organism movement law/If yes, does the product comply with Directive 2001/18/EC transposed in the Law on Circulation of Genetically Modified Organism? No/No Yes/Yes application 5.13 in annex referred to in subparagraph adds a copy of the opinion of the competent authority for a risk assessment of the distribution of a copy of the environment/Attach any written consent (s) of the competent authorities to the deliberate release it into the environment of the GMO for research and development provided by the where clause for the purpose Of the B of the above-mentioned Directive (Annex 5.13) 3. scientific/SCIENTIFIC advice 3.1 Or for veterinary medicinal products has been made a formal scientific opinion from the European Medicines Agency Committee for veterinary medicinal products/ Was there formal scientific advice given by the CVMP veterinary medicinal product for this? No/No Yes/Yes if yes yes/If date (yyyy-mm-dd) scientific opinion/Date number/reference of the scientific advice letter submission 5.14. in the annex referred to in subparagraph adds a copy of the scientific opinion/Attach copy of the scientific advice letter (Annex 5 .14A) Or 3.2 is a scientific assessment of the Member States of the European Union (s)/Was (s) there in the scientific recommendations given by the Member State (s) the veterinary medicinal product for this? No/No Yes/Yes if Yes/If yes/Member the Member State (s) State (s) date (s) (yyyy-mm-dd) 4/Date (s). Other submissions for registration certificate/OTHER MARKETING AUTHORISATION applications 4.1 ONLY the national procedure for registration, fill in accordance with no. 9 and paragraph 11 600/For national applications only, please complete the following in accordanc with article 12 (1) of Directive 2001/82/EC transposed in the article 9 and 11 of the Regulations of the. 4.1.1.600 or of any other Member State (s), where is filed an application for the same veterinary medicinal product */Is there another Member State (s) where an application for the same * product is pending? Yes/Yes No/No if the answer is "Yes", fill out the application, point 4.2/If yes, section 4.2 must be completed 4.1.2. Or in another Member State, the certificate of registration is issued for the same areas veterinary medicinal products/Is there another Member State (s) where an authorisation is granted for the same product? *
Yes/Yes No/No if the answer is "Yes", fill out the application and add 4.2 registration certificate copy/If yes, section 4.2 must be completed and a copy of the authorisation provided Or there is any difference in therapeutic effect, shown in this application and the application in the same registration certificate of the veterinary medicinal product in other Member States? (The national rules applicable to application No. 600, 47 and 48 46.) Is there any difference/it's which have therapeutic implications between this application and the application/authorisation for the same product in the other Member States? (for national applications, article 21 or 22 of Directive 2001/82/EC transposed in the article 46, 47, 48 of the Regulation shall apply From. 600).
Yes/Yes No/No if yes, describe If yes, please/-4.1.3 elaborat or other competent authority in the Member State of registration is refused, withdrawn or suspended for the same veterinary medicinal products/Is there another Member State (s) where an authorisation was suspended/revoked/refused by the competent authorities for the same product? * Yes No if the answer is "Yes", fill out the application, point 4.2/If yes, section 4.2 must be completed registration application 4.2 the same as veterinary medicinal products of the European economic area country veterinary medicinal products/Marketing authorisation application for the same * product in the EEA registered/state/country of the Authorised Registration date (yyyy-mm-dd)/date of authorisation (yyyy-mm-dd) name/invented name registration certificate number/authorisation number of the application referred to in subparagraph annex 5.15 the registration certificate (copy)/Attach marketing authorisation (Annex 5.15) stage of Proceedings/Pending state/ country date of filing (yyyy-mm-dd)/date of submission (yyyy-mm-dd) rejected the State/country/Refused withdrawal date (yyyy-mm-dd)/date of refusal (yyyy-mm-dd) withdrawn (before registration)/Withdrawn (by the applicant before authorisation) state/country: Withdrawal Date (yyyy-mm-dd)/date of withdrawals (yyyy-mm-dd) name/name revocation reason invented/reason for withdrawals revoked (the applicant after registration)/Withdrawn (by the applicant after authorisation) country/country of the withdrawal date (yyyy-mm-dd)/date of withdrawals (yyyy-mm-dd) number of the registration certificate/authorisation number, the reason for the revocation reason/withdrawals/invented the name given name stopped or cancelled (competent authority),/Suspended/revoked (by the competent authority) country/country of suspension or cancellation date (yyyy-mm-dd)/date of suspension/revocation (yyyy-mm-dd) the suspension or cancellation reason/reason for suspension/revocation/invented the name given name 4.3. multiple submissions for the same veterinary medicinal product */For multiple applications of the same medicinal product more of veterinary submissions/multiple applications for: another name of the veterinary medicinal product (s) in the/Name of the other product (s) submission (s) date (yyyy-mm-dd)/Date of application (s) (yyyy-mm-dd) the applicant (s)/Applicant (s) 4.4 registration submissions outside of the European economic area for the same veterinary medicinal product/Marketing authorisation application for the same * product outside the EEA registered/state/country of the Authorised Registration date (yyyy-mm-dd)/date of authorisation (yyyy-mm-dd) name of invented name review/stage/state/country Pending the submission date (yyyy-mm-dd)/date of submissions (yyyy-mm-dd) rejected the State/country/Refused withdrawal date (yyyy-mm-dd)/date of refusal (yyyy-mm-dd) withdrawn (before registration)/Withdrawn (by the applicant before authorisation) state/country : recall the date (yyyy-mm-dd)/date of withdrawals (yyyy-mm-dd) name/name revocation reason invented/reason for withdrawals revoked (the applicant after registration)/Withdrawn (by the applicant after authorisation) country/country of the withdrawal date (yyyy-mm-dd)/date of withdrawals (yyyy-mm-dd) number of the registration certificate/authorisation number, the reason for the revocation reason/withdrawals/invented the name given name stopped or cancelled (competent authority),/Suspended/revoked (by the competent authority) country/country of suspension or cancellation date (yyyy-mm-dd)/date of suspension/revocation (yyyy-mm-dd) the suspension or cancellation reason/reason for suspension/revocation/trade name Trade name note. * The same veterinary drug is a medication with the same qualitative and quantitative content of active substances and pharmaceutical form as veterinary medicinal products for which a registration application has been filed in another Member State and that the applicant is the same as that submitted the application for registration of the medicinal product concerned in another Member State (or the applicant belong to the same groups of economic operators). Note. The "same product" means same and composition in a quantitativ qualitativ active substance (s) and having the same pharmaceutical form from applicants belonging to the same mother company or group of companies or by a "license" which.
5. Annexes (if necessary)/ANNEXED documents (where appropriate) 5.1. Proof of payment/Proof of payment to 5.2. The original registration certificate of the veterinary medicinal product by the holder of the letter of consent in accordance with Regulation No 600 3. Informed consent section 5.15/letter holder of an authorisation of marketing veterinary medicinal product 5.3. Proof that the applicant is established in the European economic area country/Proof of establishment of the applicant in the EEA 5.4. The applicant or holder of the registration certificate issued to the authority for communication with competent authority/Letter of authorisation for communications on behalf of the applicant/MACH 5.5. The qualified person responsible for pharmacovigilance CV (curriculum vitae)/Curriculum Vita of the Qualified Person for the specific 5.6. Special permit (license) for the manufacture of veterinary medicinal products. The reference to Eudr is sufficient if GMP is available/Manufacturing Authorisation required under article 44 of Directive 2001/82/EC transposed article 6 in the Cabinet Regulations From 319 (or equivalent, outside of the EEA or other Community where MR. arrangements will apply). A reference to the Eudr of the GMP will suffic when available 5.7. Evidence that more than one producer is responsible for the serial output/Justification for more than one manufacturer responsible for batch release in the EEA 5.8. Production flow map that indicates all veterinary medicinal products or active substances involved in the production process the production sites (areas that involve sampling and testing for serial output products that are produced in third countries). Note the. You must specify all the production and control of the places referred to in the documentation accompanying the application (dossier) (indicate the name, address and details of action taken)/Flow-chart indicating all sites involved in the manufacturing process of the veterinary medicinal product or the active substance (including sites involved in sampling and testing for batch release of products manufactured in third countries). Note: ALL manufacturing and control sites mentioned throughout the whole dossier must be consistent regarding their names, detailed address and activities of 5.9. The certificate (or the GMP certificate issued by the competent authority in the EEA, if available) of compliance with GMP, issued by the competent authority which carried out the inspection of the production of space (no older than 3 years)/Statement (or GMP certificate issued by an EEA, the Inspectorate when available) from the competent authority which carried out the inspection of the manufacturing site (s) (not older than 3 years). Reference to the GMP is sufficient Eudr if available. If applicable, add the information about the last two years of the GMP inspection results made/reference it Eudr GMP will suffic when available. Where applicable (a) a summary of the GMP inspection performed by others in the last 2 years 5.10. Access to licence for the active substance master file or the European Pharmacopoeia, a copy of the certificate of conformity/Letter (s) of access to active substance Master file (s) (Drug Master file (s)) or copy of Ph Eur. Certificate (s) of suitability 5.11. The manufacturer of the active substance, written confirmation that the applicant will be notified of changes to the manufacturing process or specifications in accordance with Regulation No 600/Copy of written confirmation from the manufacturer of the active substance notified the applicant in case of modification of the manufacturing process or specifications according to Annex I of Directive 2001/82/EC transposed in the Cabinet Regulations No. 600 5.12. The European Pharmacopoeia, a certificate of conformity for the monitoring of transmissible spongiform encephalopathies (TSE)/Ph. EUR. Certificate (s) of suitability for TSE 5.13. Written consent of the competent authority in relation to the release into the environment of GMOs/Written consent (s) of the competent authorities regarding the GMO release in the environment 5.14. Scientific opinion from the European Medicines Agency's Committee for medicinal products or/Scientific advice given by CVMP ora Member State 5.15. Registration certificate (s) (s) issued to a European economic area country and in third countries equivalent certificates issued copy (photocopies of the lapaspuš, which shows the number of the registration certificate, date of issue and the page signed by the responsible person of the competent authority)/Copy of Marketing Authorization (s) required under article 44 of Directive 2001/82/EC in the EEA and the equivalent in third countries on request (a photocopy of the pages which give the marketing authorization number , the date of authorisation and the page which has been signed by the authority competent authorizing will suffic) 5.16. Correspondence with the European Commission about the multiple submission/Correspondenc with European Commission regarding multiple applications 5.17. The marketing of packaging mock-ups or samples of the label list, submitted together with the application/list of Mock-ups or Sample/specimen is sent with the application, as appropriate (see notice to applicants, volume 6A, Chapter 7) 5.18. The suggested name and awarded a certificate of registration of owners of the participating Member States list/list of proposed (invented) name and marketing authorisation holder in the member States concerned 5.19. The production certificate holder for the raw materials should be used only in its active substances which have been manufactured in accordance with GMP, therefore to add each production licence holder (the relevant active substances used as starting materials) the Declaration that the active substance production in accordance with GMP. In addition to each qualified person responsible for the serial output, is responsible for each of the series, it is therefore necessary to add the serial output of the Declaration by the qualified person in charge, if the serial output location different from above/Manufacturing authorisation holder is obliged to only use it as starting materials of active substance that have been manufactured in accordanc with a declaration is expected from GMP so each of the manufacturing authorisation holder that use the active substance as a starting material. In addition, the QP will for batch certification takes overall responsibility for each batch, a further declaration from the QP responsible for batch certification is expected when the batch release site is a different site from the above. In many cases it is involved only one producer and only one declaration is required. However, if the production is involved in more than one production licence holder, many manufacturers declaration you can submit one declaration, signed by the qualified person. This is acceptable if: 1) are clearly indicated in the statement that it has signed all the qualified persons; 2) approved the arrangement, on the basis of the technical agreement of the GMP guidelines, described in section 7, and one qualified person who makes a declaration, has been identified as a particular decision (specific) in charge of compliance with GMP manufacturer of the active substance (s). Note the. This contract is subject to inspection by the competent authority In many cases/only one manufacturing authorisation holder is involved and therefore only one declaration will be required. However, when more than one manufacturing authorisation holder is involved rather than provide multiple declarations it may be to provide a acceptabl single declaration signed by one QP. This will be accepted provided that: a the declaration makes it clear that it is signed on behalf of all the involved QP. The subject is underpinned by a technical to the agreement as described in Chapter 7 of the GMP Guide and the QP providing the declaration is the one identified in the agreement as taking specific responsibilty for the GMP compliance of the active substance manufacturer (s). Note. These arrangements with the subject to inspection by the competent authorities to be. Applicants are reminded that a qualified person is the holder of a production licence in accordance with Regulation No 319 paragraph 7 and located in the European economic area country. Therefore, the Declaration of the personnel employed in the manufacture of veterinary medicinal products from third countries, including mutual recognition agreements (MRA) partner countries, is not acceptable to reminded the applicants/you a Qualified Person is at the disposal of (a) the manufacturing authorisation holder according to the art. 50 of Directive 2001/82/EC and located in the EEA. Therefore the declaration from personnel employed by manufacturers in third countries, including those located within MR. partner countries not acceptabl ... Production includes all or part of the production process, importation, packaging, packing or preparation prior to the inclusion of veterinary medicinal products, including repackaging and pārmarķēšan by the dealer/According to article 50 (1) of Directive 2001/82/EC manufacture includes complete or partial manufacture, import, dividing up, packaging or presentation prior to its incorporation into a medicinal product, including re-packaging or labelling as carried out-by a distributor 5.20. Detailed safety monitoring the use of the medicinal product (pharmacovigilance) description of the system and, if necessary, a risk management system used by the applicant to the site/Detailed description of the Specific system and, where appropriate, the risk management system that the applicant will put in place ".
Prime Minister v. dombrovsky, Minister for Agriculture of the rapidity of L.