Key Benefits:
Arrangement of the Minister for Economic Affairs of 3 December 2014, No WJZ/13149501 implementing the Animal Trials Act and the Animal Test 2014 (Animal Testing 2014).
The Minister for Economic Affairs,
Having regard to Directive No 2010/63 /EU of 22 September 2010 on the protection of animals used for scientific purposes, the Articles 1, first paragraph, part 1 , 3 , 10a, fifth member , 10a1, seventh member , 11a, second member In conjunction with Article 3 , and 19, second paragraph, point (d) of the Animal Testing Act and the Article 2, second paragraph , 3 , 8, 1st Member , 11, 1st Member and 12 of the Animal Act 2014 ;
Decision:
The following definitions shall apply:
- Decision: The Animal application decision 2014 ;
- Diploma: diploma as referred to in Article 7.4.6 of the Education and Vocational Education Act ,
- Certificate: certificate as intended in Article 7.11 of the Law on Higher Education and Scientific Research ,
- Setting permit: an institution permit as referred to in Article 2 and 11a of the Act ;
- qualification file: qualification file within the meaning of Article 1.1.1, part 1, of the Education and Vocational Education Act ;
- Life-case file: the life-case file referred to in Article 15a, second paragraph, of the Act ;
- Minister: the Minister for Economic Affairs.
2 As a Directive, intended to Article 1, first paragraph, part (i) of the Act shall be designated: Directive 2010 /63/EC of 22 September 2010 on the protection of animals used for scientific purposes (PbEU L 276/33).
1 An application for an institution permit shall be submitted using the form in Annex 1 This scheme.
2 Upon submission of an application, an amount of € 1,883.30 is due.
3 After the authorisation of the institution is issued, the holder of authorisation shall notify our Minister without delay:
a. any change to the persons referred to in Article 6, third paragraph, of the Act ;
b. any significant change in the structure or operation of a device of the holder of the authorisation, which may adversely affect animal welfare.
1 In case of application for a project permit as intended Article 10a, first paragraph, of the Act the following information and documents shall be consulted:
a. The information contained in the third paragraph;
b. the project proposal; and
c. the non-technical summary of the project according to Article 4 .
2 An application to a project permit is submitted using the form in Annex 2 in this scheme and the format for the project proposal in Annex 3 This scheme.
3 Upon application, the applicant shall provide that information necessary to demonstrate, to the extent relevant, that the rules are being complied with or under the conditions of Article 2, second and third paragraphs , 9 , 10 , 10a2, 1st Member , 10b and 13f of the Act . The application shall, in any event, contain the following information:
a. The interest as intended in Article 2 (2), second and third paragraphs, of the Act to which the animal experiments in the project are addressed;
b. the objectives of the project and the predicted scientific returns or educational value of the project, or the legal requirement as intended in Article 10a2, first paragraph, point (a) of the Act ;
(c) a description of the animal experiments, including the intended treatment of the animals and the nature, frequency and duration of the operations to which the animal is subjected;
d. the user who is performing the project;
e. the person or persons responsible for the overall implementation of the project and for the conformity of the project with the project authorisation granted;
f. where appropriate, the establishments in which the project will be implemented;
g. if applicable, the reasons specified in Article 10a2, second paragraph, point (e) of the Act ;
h. the data contained in Annex 4 This scheme.
4 Upon submission of the application for a project authorisation, an amount determined by the Central Committee on Animal Health and approved by the Minister shall be fulfilled. The amount is a lump sum that covers the average costs associated with handling an application to obtain a project permit. Notice of the approval decision referred to in the first sentence shall be communicated by the State Official Gazette.
1 For the non-technical summary of the project and any additions thereto as a result of changes as intended Article 10a5 of the Act , or an ex-post assessment of the project as intended Article 10a1, first paragraph, point (d) of the Act , the applicant shall make use of the in- Annex 5 model included in this arrangement.
2 Without prejudice to the protection of intellectual property and confidential information, the non-technical summary shall contain the following information:
a. information on the objectives of the project, including the predicted damage and benefits, and the numbers and types of animals to be used;
b. underpinning that to the requirement in the field of replacement, reduction and refinement as laid down in the Articles 1d and 10, second paragraph, of the Act shall be satisfied.
3 The applicant shall ensure that the non-technical summary is anonymous and does not include names and addresses of the user and its staff.
4 The Central Committee on Animal Testing shall publish the non-technical summary as soon as possible after the issue of a project authorisation, and shall, where appropriate, state that the project is assessed subsequently, and within what time limit. The Central Committee on Animal testing shall make any additions to a non-technical summary as a result of amendments to the Article 10a5 of the Act , or an ex-post assessment of the project as intended Article 10a1, first paragraph, point (d) of the Act , as soon as possible after receiving public. The Central Committee on Animal testing shall ensure that the non-technical summary can be completed five years after the completion of the project, or, where appropriate, five years after the completion of the evaluation of the project. I've seen it through a searchable online database.
1 The scientific training provided for in Article 2, first paragraph, of the Decision , consists of a master ' s degree in a relevant study direction.
2 The course laboratory course, intended in Article 2, first paragraph, of the Decision , meets the requirements in Annex 6 This scheme.
3 The Minister may, upon request, grant a waiver of the requirement in paragraph 1 if otherwise demonstrated that the person is intended to be Article 9 of the Act , it has a similar level of competence and competence.
1 The training provided in Article 8, first paragraph, of the Decision , comply with the following minimum requirements:
(a) in respect of the person taking care of animals and carrying out one or more biotechnical operations referred to in point (a) of the third paragraph, or of the animals referred to in that subparagraph: the qualification file for Proefanimals, Crebonumber 97770 or 95360, or the requirements for the animal care training course, as described in the qualification manager for Proefanimal caregiver, Crebonnumber 25449, or the requirements set out in ' Curriculating requirements for a recognition ex Article 6 of the Animal Proper Scheme 2014 at HBO level ' such as published on http://www.rijksoverheid.nl/documenten-en-publicaties/besluiten/2015/08/01/opleidingseisen-tbv-een-erkenning-ex-artikel-6-proefdierverzorger-op-hbo-niveau.html;
b. In respect of the person carrying out animal testing, where one or more biotechnical operations referred to in point (b) of the third paragraph are carried out or animals referred to in that section are killed: the requirements for the training biotechnician such as described in the qualification file Proefanimals, Crebonummer 97780 or 95370, or the requirements for the training specialist for animal care as described in the qualification file Specialised laboratory animal care, Crebonummer 25466, or Requirements laid down in ' Curricula requirements for the purpose of recognition ex Article 6 of the Animal feed scheme 2014 at HBO level ' as published on http://www.rijksoverheid.nl/documenten-en-publicaties/besluiten/2015/08/01/opleidingseisen-tbv-een-erkenning-ex-artikel-6-biotechnicus-op-hbo-niveau.html;
c. in respect of the person who kills small experimental animals: the requirements for the Euthanaseren choice of small experimental animals, part of the training experimental animal as described in the qualification file Proefanimal carer, Crebonnumber 25449.
2 The Minister may, on request, grant a derogation from the requirement in paragraph 1 if it is otherwise demonstrated that the person taking care of animals carrying out animal or experimental animals carries out biotechnical work or kills experimental animals, has a a similar level of competence and competence. The exemption may be limited to specific work on experimental animals.
3 The following shall be the subject of the following activities to be carried out on the following persons:
a. performing some simple biotechnological acts, such as taking blood, giving oral insertion, administering simple injections, removing sutures and taking responsible and simple killing of small children. 'experimental animals' means those who possess a diploma or certificate recognised by the Minister for the training referred to in paragraph 1 (a) or (b) and the person meeting the criteria of competence and competence specified in the person concerned, Article 9 of the Act , and which has the necessary knowledge and experience to carry out biotechnical operations and activities;
(b) carrying out any other biotechnical work other than those referred to in (a), such as caning (blood) vessels, taking away (parts of) organs, applying (inhalation) anaesthesia, using more complex methods than those specified in Part a responsible killing of small experimental animals and the responsible killing of large experimental animals: the person holding a diploma or certificate approved by the Minister for the training referred to in paragraph 1 (b); and the person who fulfils the competence and competence requirements of the person, Intended in Article 9 of the Act , and who has the necessary knowledge and experience to carry out the biotechnical operations and work.
(b) the killing of small experimental animals in a responsible manner: the person holding a diploma or certificate approved by the Minister for the training referred to in the first paragraph, parts a, b or c.
4 By way of derogation from the third paragraph, in the context of training for the persons concerned, Article 9 of the Act and Article 8 of the Decision the work referred to therein shall be carried out by persons who do not yet have the necessary skills and competence, provided that such work is carried out under the supervision of a person who does possess the necessary qualifications and expertise.
By way of derogation from Article 14a, first paragraph, of the Act , the following categories of breeders, suppliers and users are not required to set up an animal welfare authority:
a. Breeders who:
-not more than one thousand animals per year of breeding, and
-no dogs, cats, non-human primates, endangered species as intended in Article 10th, third paragraph, of the Act breeding or genetically modified animals;
b. Suppliers not holding or delivering non-human primates;
c. Users who:
-do not carry out animal experiments on dogs, cats, horses, non-human primates, endangered species as intended Article 10th, fourth paragraph, of the Act or stray animals; and
-carry out only tests on animals which do not produce more than minor inconvenience and consist exclusively of routine, simple operations.
1 The breeder, the supplier and the user shall keep records of the following particulars:
a. The number of animals, per species, which was bred, acquired, supplied, used in animal experiments, released or adopted;
b. the origin of the animals, including whether they were bred for use in animal experiments;
c. the use of the animals;
d. the date on which the animals were acquired, delivered, released or adopted;
e. the animals of which the animals are involved;
f. the name and address of the customer of the animals;
g. the number of animals, by species, which has died or been killed in each establishment; for the dead animals, the cause of death, if known, shall be recorded; and
h. for users: the projects in which animals are used.
2 The data referred to in paragraph 1 shall be kept for up to five years after the end of the calendar year to which the data relate.
3 The breeder, the supplier and the user shall forward to the Minister every year no later than 15 March the Annex 7 data referred to in this scheme for the previous calendar year.
1 In addition to the provisions of Article 8 hold the breeder, the supplier and the user about each dog, cat and non-human primate they keep note of the following data:
a. Identity;
(b) place and date of birth, if available;
c. reply to the question of whether the animal has been bred for use in animal experiments; and
d. in the case of non-human primates, answer to the question whether the animal is a descendant of non-human primates bred in captivity or coming from self-contained breeding colonies.
2 The life-case file shall be opened at the birth of the animal, or as soon as possible thereafter, and shall contain all relevant information on reproductive activity, veterinary status and social behaviour of the animal in question and on the basis of projects in which it has been used.
3 The breeder, supplier and user shall retain the data referred to in paragraphs 1 and 2 for at least three years following the death or adoption of the animal. In the case of adoption, the institution shall communicate the relevant data on the animal health situation and the social behaviour of the life-case file with the animal.
In addition to the tasks mentioned in Article 19, second paragraph, points (a) to (c) of the Act , the national committee shall carry out the following tasks:
a. promotes the development, validation, acceptance and application of alternatives to animal testing both nationally and internationally;
b. advises the government, the central committee on animal testing, animal welfare and persons ' means of animal welfare Article 13f, third paragraph, part a, of the Act on alternatives to animal testing;
c. bundles the input into international greymia and hereby devotes it;
d. supports communication between and with professionals in the field of animal experiments and alternatives and provides public communication about animal experiments and alternatives.
1 With a derogation based on Article 5, third paragraph , shall be treated as one before the entry into force of the Law amending the Act on Animal Testing in Connection with Implementation of Directive 2010 /63/EU on the basis of Article 16 of the Act derogation granted, to the extent that it relates to the requirement that the person referred to in Article 9 of the Act has a master ' s degree in a relevant study direction.
2 With a waiver on the basis of Article 6, second paragraph , shall be treated in the same way as before the entry into force of the law amending the Act on Animal Testing in relation to the implementation of Directive 2010 /63/EU on the basis of Article 16 of the Act derogation granted, in so far as this waiver relates to training requirements in respect of persons taking care of animals, carrying out biotechnical work or killing experimental animals.
This arrangement shall enter into force at the time of its entry into force. Animal application decision 2014 enters into force.
This scheme is cited as: Animal pilot scheme 2014.
This arrangement will be set out in the Official Journal.
' s-Gravenhage, 3 December 2014
TheState Secretary
of Economic Affairs,S.A.M. Dijksma
Application form for the institution's authorisation form:
-ex Article 2 Animal testing law (hereafter Wod) (user) 1
-ex Article 11a Wod (breeder)
-ex Article 11a Wod (vendor)
-All ex Article 2 and ex Article 11a Wod
1. Applicant
Setting name:
Name responsible on behalf of the institution/portfolio holder:
Nature of the institution 2 :
If applicable, KvK number:
Address:
Postal code and place name:
Telephone:
2. Person or persons within the institution responsible for the overall implementation of the project and for the conformity thereof with the project authorisation granted, intended Article 13f, fourth paragraph, part b, of the Wod
1. Name:
Function:
2. Name:
Function:
3. Person or persons referred to in Article 13f, third paragraph, of the Wod
a. The person or persons on the spot responsible for the supervision of the welfare and care of the animals in the establishment
1. Name:
Function:
2. Name:
Function:
b. The person or persons on the ground who ensure that staff handling the animals have access to specific information concerning species housed in the establishment
1. Name:
Function:
2. Name:
Function:
c. The person or persons on the ground who ensure that staff are sufficiently skilled and competent to be continuously trained and supervised until they have provided proof of the necessary qualifications
1. Name:
Function:
2. Name:
Function:
4. Person or persons referred to in Article 14 of the Wod
1. Name:
Function:
2. Name:
Function:
5. Housing experimental animals
(complete if not housed at above address to 1, indicate any number of locations on which animals are housed in an annex, provided with a home address):
Address:
Postal code and place name:
Telephone:
6. Signature
The authorisation holder shall:
Name:
Function:
Place:
Day Drawing:
Signature:
• You are planning to carry out one or several animal tests.
• Use this form to request a permit for the project that you want to run. Or, you specify what you want to change in the permit project.
• More information on the terms and conditions can be found on the website www.zbo-ccd.nl or in the comments on the website.
• Or get in touch by phone.
1. Applicant Data
| 1.1 Fill in the participation number of the institution. |
Number: |
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| 1.2 Fill in the data of the institution holder applying for the project authorisation. |
Institution or Organization Name |
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| Name of the portfolio holder or his authorised representative |
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| KvK Number |
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| 1.3 Please fill in the postal address details. All correspondence from the CCD shall go to the portfolio holder or his authorised representative and the investigator responsible. |
Street and house number |
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| PO Box |
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| Postal code and location |
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| IBAN |
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| Account number of the account number |
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| 1.4 Fill in the data of the investigator responsible. |
(Title) Name and initials |
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| Function |
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| Section |
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| Telephone number |
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| Email address |
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| 1.5 (Optional) Fill in the data of the deputy responsible investigator. |
(Title) Name and initials |
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| Function |
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| Section |
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| Telephone number |
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| Email address |
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| 1.6 (Optional) Fill in the data of the person responsible for the project's execution in accordance with the project permit. |
(Title) Name and initials |
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| Function |
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| Section |
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| Telephone number |
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| Email address |
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| 1.7 Is there an authorised representative for this project request? |
Yes/No |
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2. About your request
| 2.1 What request do you do? |
0 New application 0 Modification to (granted) permit that may have a negative impact on the welfare of animals: Awarded project number ________________ Notification to (issued) permit that cannot have a negative impact on animal welfare: Grant project number ________________ |
| 2.2 Is this a Change for a project or animal test that has already been licensed for? |
Yes/No |
| 2.3 Is this a notification for a project or animal test that has already been authorised? |
Yes/No |
3. About your project
| 3.1 What is the planned start and end date of the project? |
Start Date End Date |
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| 3.2 What is the title of the project? |
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| 3.3 What is the title of the non-technical summary? |
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| 3.4 What is the name of the Animal Experiment Commission (DEC) to whom the institution-holder usually submits its projects for review? |
DEC Name |
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| Postal address |
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| Email address |
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4. Payment data
| 4.1 What type of request is it? |
0 New Application Project License €______ Lege 0 Change: € _______Lege |
| 4.2 The manner in which you intend to comply with this amount to the CCD. In the case of a one-off direct debit, you consent to the CCD to write off the amount specified by 4.1 once the account number specified at the value of 1.2. |
0 Via a one-off direct debit 0 After Receipt of the invoice |
5. Checklist attachments
| 5.1 What attachments are you sending? |
Mandatory |
Project proposal 0 Non-technical summary |
| Other annexes, if applicable |
0 Permission Notification 0 |
6. Signature
| 6.1 Print out the form, sign it, and send it with attachments via the secure email connection or by mail to the CCD. |
Signature by the institution-holder or authorised representative (see 1.6). The undersigned hereby declares that: • that the project proposal is aligned with the Animal Welfare Authority. • the persons responsible for the design of the project and for the animal test, the persons taking care and/or killing the animals and the persons carrying out the animal tests comply with the legal requirements of expertise and competence. • that the animals are housed and cared for in a manner that meets the requirements set out in Annex III of this Regulation. Directive 2010/63 /EU, except in the case provided for in Section F of the Annex to the project proposal, which is attached to the application, with justified exceptions. • the signature of this form is subject to the obligation to pay the fee for the processing of the application. • that the form has been completed in full and in truth. |
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| Date |
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| Signature |
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• This format will be used to write your project proposal from the animal experiments.
• In this format, the Annex Description should be included in the Annex Description. For each type of animal test, you must add this Annex.
• More information on the project proposal can be found on the website www.zbo-ccd.nl.
• Or get in touch by phone.
1. General details
| 1.1 Fill in the participation number of the institution. |
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| 1.2 Fill in the name of the setting or organization. |
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| 1.3 Fill in the title of the project. |
2. Category of project
| 2.1 In what category is the project. You can choose multiple options. |
0 Fundamental research |
0 Research on the conservation of the animal species |
| 0 Translational or applied research |
0 Higher education or training |
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| 0 Legally required research or routine production |
0 Forensic investigation |
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| Research for the protection of the environment in the interest of the health or welfare of humans or animals |
0 Preservation of colonies of genetically modified animals, not used in other animal experiments |
3. General project description
| 3.1 Background |
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| Light up the project. Describe the reason, the background, and the context. Pay attention to the update 2. Cross-categories -In the case of "animal testing required by law", please indicate the legal requirements applicable (in relation to intended use and market admission). -In the case of 'routine production', please indicate the product (s) concerned and for which application (s). -In the case of 'higher education or training', please explain why in this project, in relation to the training programme and the final terms, is chosen for |
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| 3.2 Purpose |
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| Describe the overall objective and feasibility of the project. -In case the project is focused on one or more research targets: on which vra (a) g (s) should this project provide response (s)? -In the case of other than research purposes, what concrete need does this project foresee? |
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| 3.3 Importance |
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| Describe the scientific and/or social importance of the objective (s) described above. |
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| 3.4 Research strategy |
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| 3.4.1 Provide an overview of the overall design of the project (strategy). |
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| 3.4.2 Summary of the various elements of the project and the type (s) of animal test or animal testing used in the project. |
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| 3.4.3 Describe and identify the logical coherence of these various components and the possible phasing out in the implementation. Enter any milestones and choices. |
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| 3.4.4 The types of animal testing shall be carried out. For each type of animal test, please complete an Annex Description of animal experiments. |
Order No |
Type of animal test |
| 1 |
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| 2 |
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| ... |
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4. Signature
| 4.1 Please sign the form and forward it. Print out the form, sign it, and send it with attachments through the secure email connection or by mail to the CCD. For each type of animal test, please insert the animal testing annex description. |
I have completed this form completely and in truth. |
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| Name |
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| Date |
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| Signature |
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• This annex adds animal experiments to your project proposal.
• For each type of animal test, complete this Annex and add it.
• For more information, see the website www.zbo-ccd.nl.
• Or get in touch by phone.
1. General details
| 1.1 Fill in the participation number of the institution. |
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| 1.2 Fill in the name of the setting or organization. |
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| 1.3 Fill in the serial number and the type of animal test. Use the order numbers of question 3.4.4 of the format Project proposal. |
Order No |
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| Type of animal test |
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2. Animal testing description
| A. Experimental approach and primary provenance parameters -Describe the choice of the experimental and the primary provenance parameters. -Describe the intended treatment of the animals (including the nature, frequency and duration of the treatments to which the animals are exposed) and under construction the chosen approach. -Indicate what considerations and statistical methods are used to minimise the number of animals needed. |
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| B. The animals Identify animal species, origin, estimated numbers and life stages. Underbuild these choices. |
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| C. Reuse -Is there any reuse of animals? -If yes, please indicate on the basis of which recovery considerations are considered acceptable in this case. |
Yes /No |
| -Are there any (or a risk of) serious inconvenience in the preceding or planned use? -If yes, please indicate on the basis of which recovery considerations are considered acceptable in this case. |
Yes/No |
| D. Substitution, reduction and refinement -demonstrate how the application of methods of substitution, reduction and refinement have been taken into account in determining the experimental strategy, the choice of animals and the design of the animal test and what choices have been made. -Indicate what measures have been taken to minimise the risk of pain, suffering or anxiety in the animals and the risk of adverse effects on the environment. |
Recurrence/duplication
| E. Recitation Please indicate how it has been verified that these animal experiments have not been carried out before. If appropriate, specify why duplication is necessary. |
Housing and care
| F. Housing and care services -the animals shall be treated as different from the requirements of Annex III of the Directive. Directive 2010/63 /EU housed and/or cared for? -If so, if this can result in adverse animal welfare effects, please indicate how the animals are housed and cared for and justify the choice to deviate from the requirements set out in the abovementioned Annex III. |
Yes /No |
| G. Place where the animals are housed -Are the tests carried out in whole or in part in an establishment which does not fall under the direct responsibility of an institution holder of the authorisation of Wod? -If yes, please indicate what business or institution is concerned with. -Why has this been chosen, and how is adequate housing, care and treatment of the animals guaranteed? |
Yes /No |
Unestimation/Humane Endpoints
| H. Pain and pain management -Is there any way that pain can occur in the animals? |
Yes /No |
| -If yes, are anesthesia, analgesic, and/or other pain-illumination methods applied in that case? -If the answer to the previous question is 'no', please explain why no pain relief methods are applied. |
Yes /No |
| I. Other deterioration of welfare and measures -What are the possible other forms of social impairment? -Indicate what the possible causes of this are. -Describe what measures are being taken to prevent these harmful effects or where possible, to minimise them. |
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| J. Humane Endpoints -Is there circumstances which arise in the animal test in which the use of humane endpoints is indicated in order to prevent further suffering from the animals? -If so, please specify the criteria to be used in this respect. -What percentage of animals are likely to meet these criteria? |
Yes /No |
| K. Classification of uncleaned Please indicate how in the light of all the negative effects described above, the cumulative level of inoperative is classified in terms of ' terminal ',' light ',' moderate ' or 'severe' Uncleaned. |
End Experiment
| L. Wise of dead -Are the animals killed as part of the experiment or at the end of the experiment? -If yes, please indicate why killing animals as an endpoint is essential for this trial. |
Yes /No |
| -There is a method (s) of killing out of Annex IV of Directive 2010/63 /EU applied? -If the answer to the previous question is 'no', the euthanasia method and underconstruction describe the choice for this. |
Yes/No |
3. Signature
| 3.1 Please sign the form and forward it. Print out the form, sign it, and send it through the secure email connection or by mail to the CCD. For each type of animal test, carry out the Annex Description animal testing. |
I have completed this form completely and in truth. |
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| Name |
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| Date |
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| Signature |
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The following information shall be provided in the application for a project authorisation:
1. relevance and justification of:
-the use of animals, including their origin and the estimated number and types and stages of life;
-the animal experiments.
2. application of methods of substitution, reduction and refinement of the use of animals in animal experiments;
3. planned use of anesthesia, analgesia and other pain relief methods;
4. reduction, avoidance and alleviation of all forms of animal suffering from birth to death, where appropriate;
5. the use of humane endpoints;
6. use the experimental or observation strategy and the statistical model to minimise, where appropriate, the number of animals, their pain, suffering, and fear and the environmental effects;
7. the re-use of animals and the accumulative effect on the animal;
8. the proposed classification according to the seriousness of the animal experiments referred to in Article 10b, first paragraph, of the Act ;
9. avoidance of unwarranted duplication of animal experiments, where appropriate;
10. the conditions in which the animals will be housed, kept and cared for;
11. methods of killing;
12. the competence of the persons involved in the project.
| Title of the project |
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| Duration of the project |
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| Keywords (maximum 5) |
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| Objective of the project |
Basic research |
Yes |
No |
| Translational or applied research |
Yes |
No |
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| Legally required research or routine production |
Yes |
No |
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| Environmental protection for the benefit of the health or welfare of humans or animals |
Yes |
No |
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| Research focused on the conservation of the animal species |
Yes |
No |
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| Higher education or training |
Yes |
No |
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| Forensic examination |
Yes |
No |
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| Preservation of colonies of genetically modified animals, not used in other animal experiments |
Yes |
No |
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| Describe the objectives of the project (e.g. scientific question or scientific and/or social interest, including the clinical relevance). |
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| What revenues are expected from this project and how do they contribute to the scientific and/or social interest, including the importance of human or animal health or nutrition? |
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| Which animal species and estimated numbers will be used? |
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| In this project, what are the expected negative effects on the welfare of the test animals? 1 How are the animal experiments in the project classified according to the expected severity? 2 What is the destination of the animals afterwards? |
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| The Three V' s |
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| 1. Replacement Please indicate why the use of animals is necessary for the described objective and why animal-free alternatives cannot be used. |
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| 2. Reduction Please explain how it can be ensured that the number of animals as low as possible is used. |
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| 3. Refinement Explain the choice of animal species (s). Explain why the chosen animal model (s) are the most refined, having regard to the objectives of the project. Please indicate which general measures are taken to minimise the negative (harmful) effects on the welfare of the test animals. |
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1 Describe the negative effects that the animal experiments will have in this project as a result of the animal testing.
2 The severity classification as intended by Article 10b (1) of the Act on Animal Testing .
The pilot animal course intended in Article 2, first paragraph, of the Animal Act 2014 , for the person who set up the project and the animal test as intended Article 9 of the Act on Animal Testing , comply with the following minimum requirements:
Element referred to in Annex V to the Directive
Competence to be acquired in the experimental veterinary course
| applicable national legislation relating to the procurement, husbandry, care and use of animals for scientific purposes |
Knowledge of the legislation on the use of experimental animals |
| ethics in relation to the relationship between humans and animals, the intrinsic value of life, and arguments for and against the use of animals for scientific purposes |
Knowledge of the basic principles of the ethical process of degradation related to animal experiments |
| basic biology and appropriate species-specific biology with respect to anatomy, physiological features, breeding, genetics and genetic engineering |
Knowledge of the anatomical, physiological and ethological characteristics of the most commonly used test animals in relation to a proper test animal choice and an understanding of the possibilities and limitations of biological standardisation of experimental animals |
| animal behaviour, husbandry and environmental enrichment |
knowledge of the requirements of housing, nutrition and care, in particular with regard to the promotion of animal welfare, knowledge of hygiene measures and barrier systems and knowledge of safety and health risks when working with laboratory animals |
| Species-specific transition methods and procedures, if appropriate |
the necessary knowledge for a responsible manner of handling and handling experimental animals, knowledge of the different modes of loss of bodily fluids and of a number of other widely used experimental techniques |
| animal health and hygiene management |
knowledge of the potential impact of diseases in experimental animals and knowledge of health surveillance |
| recognition of species-specific symptoms of anxiety, pain and suffering in the most common laboratory species |
knowledge of recognition of pain and discomfort |
| Anaesthesia, pain relief methods and killing |
knowledge of the main forms of anaesthesia, analgesia and euthanasia that can be used in various test species |
| Use of humane endpoints |
knowledge of the definition and application of humane endpoints |
| demand for replacement, reduction and refinement |
knowledge of the possibilities of alternatives to experimental animals |
| establishment of procedures and projects |
knowledge of the possibilities of statistics to optimise experimental animal use; knowledge of environmental and experimental factors that may affect research and knowledge of quality assurance; knowledge of tools for the use of animal health; knowledge of quality assurance; knowledge of quality assurance; knowledge of quality assurance; search for alternatives, for example the EURL-ECVAM Search Guide and Go3Rs; knowledge of methods of synthesis or evidence, for example, systematic reviews and meta-analysis |
| other: knowledge of hygiene measures and barrier systems, knowledge of safety and health risks when working with experimental animals, knowledge of the different ways of decreasing bodily fluids and of a number of other widely used experimental techniques (e.g. injection techniques, oral administration and catheterization) |
|
| Species specific: • knowledge of species-specific biology with respect to anatomy, physiological features, breeding, genetics, and genetic engineering. • knowledge of species-specific manners and procedures. • knowledge of species-specific animal behaviour, • knowledge of the species-specific responsible handling and handling of experimental animals (as well as any practical skills of hand). • Knowledge of the different modes of loss of bodily fluids and of a number of other commonly used experimental techniques of the type to be used (e.g. injection techniques, oral administration and catheterisation), and some Practical hand skill with this has gained. • Knowledge gained in respect of the recognition of species-specific symptoms of anxiety, pain and suffering and the application of humane endpoints. • Knowledge of the species-specific forms of anaesthesia, analgesia and euthanasia • knowledge of the species-specific requirements of housing, nutrition and care, in particular with regard to the promotion of the welfare of animals. |
The Registration of animal experiments and experimental animals is based on: Article 8, third paragraph , from the Animal Conduct Scheme 2014 and the 2012 /707/EU implementing Decision 2012 /707/EU Directive 2010/63 /EU. Registration must be carried out by all those under Article 2, first paragraph , and Article 11a of the Act on Animal Testing (further: Wod) an institution permit to carry out animal experiments and/or for breeding and delivery of experimental animals (further: permit holder).
The registration includes four parts.
• Part 1: Data relating to the holder of the authorisation.
• Part 2: Data on the test animals present per holder of the authorisation.
• Part 3: Data on the animal experiments.
• Part 4: Data on animals in which genotyping has been applied (this is requested once every 5 years).
The data should be completed on separate transmitted digital forms (registration forms 1, 2 and 3). The forms shall be sent to the licence holders on an annual basis. The questions concerning the animal tests have been drawn up in such a way that the answers can be processed software. These answers must be placed in a specially designed form by means of the code numbers given to them. In completing the form, you must ensure that the integrity of the form is preserved, so that it remains suitable for software processing. When pasting data from another software document, you must ensure that the format of the invulation form is preserved.
The requested data should be provided by or on behalf of the holder of the authorisation.
The registration year's completed registration forms shall be sent by the holder of the authorisation as a whole, as a whole, to the Central Enforcement Animal tests of the NVWA (chd@nvwa.nl) after the end of the marketing year, before 15 March of the following year.
NVWA, Central Enforcement Animal testing
PO Box 43006
3540 AA UTRECHT
The publication of registration data shall be such as to ensure that the origin of the information cannot be established by third parties.
Registration form 1 contains information regarding the holder of the authorisation, including the address of the holder of the authorisation and, where applicable, the locations where test animals were elsewhere (outside the institution) other than on the address indicated in the form. Housed.
By signature of registration form 1, the authorisation holder declares that the registration forms are 1 to 3 correct and in accordance with the actual conditions under which the experimental animals are kept (registration form 2) and the animal experiments. have been completed (registration form 3) have been completed.
Signature should be made by the holder of the authorisation in the case of an authorised natural person and in the case of a legal person by a signed person on behalf of the holder of the authorisation.
These forms shall contain information on the origin and destination of all the animals of the test animals present within the marketing authorisation holder during the reporting year, for each animal species.
Genetically modified animals and wild fauna must be registered in forms 2b and 2c respectively; all other animals should be registered in Form 2a.
Column 1: Species
The animal species, in column 1, are to be shown in the codes available under this column. The following columns shall always show the numbers of animals that meet the description of the column concerned.
Code
| Mice ( Sparrow musculus ) |
1 |
| Rats ( Rattus norvegicus ) |
2 |
| Guinea pigs (Cavia porcellus) |
4 |
| Mongolian gerbils ( Meriones unguiculatus ) |
5 |
| Syrian gold hamsters ( Mesocricetus auratus ) |
6 |
| Chinese Dwarf Stars ( Cricetulus griseus ) |
7 |
| Other rodents Rodentia ) * |
9 |
| Rabbits ( Oryctolagus cuniculus ) |
11 |
| Dogs ( Canis familiaris ) |
21 |
| Cats ( Felis catus ) |
22 |
| Ferrets ( Mustela putorius furo ) |
23 |
| Other predators (including Carnivora ) * |
29 |
| Half-monkeys ( Prosimia ) |
31 |
| Clap monkeys (e.g. Callithrix jacchus ) |
32 |
| Rhesus monkeys ( Macaca mulatta ) |
33 |
| Java monkeys ( Macaca fascicularis ) |
34 |
| Catcats ( Chlorocebus spp. , usually C. Pygerythrus or C. Sabaeus ) |
35 |
| Bavians ( Papio spp. ) |
36 |
| Squirrel monkeys (e.g. Saimiri sciureus ) |
37 |
| Apes ( Hominoid ) |
38 |
| Non-human primates (other than species) Ceboidea and Cercopithecoidea ) * |
39 |
| Horses, donkeys and crosses thereof ( Equidae ) |
41 |
| Swine ( Sus scrofa domesticus ) |
42 |
| Goat ( Capra aegagrus hircus ) |
43 |
| Sheep ( Ovis aries ) |
44 |
| Bovine ( Bos primigenius ) |
45 |
| Other mammals Mammalia ) * |
49 |
| Fowl Gallus gallus domesticus ) |
51 |
| Other birds Aves ) * |
59 |
| Reptiles ( Reptilia ) * |
69 |
| Frogs ( Rana temporaria and Rana pipiens ) |
71 |
| Claw frogs ( Xenopus laevis and Xenopus tropicalis ) |
72 |
| Other amphibians Amphibia ) * |
79 |
| Zebra fish ( Danio rerio ) |
81 |
| Other fish (including Pisces ) * |
89 |
| Cephalopods ( Cephalopods ) |
91 |
| * You are requested to specify this in column 15. |
Column 2: Present on 1 January of the registration year.
Column 3: Own breeding within the institution. Mammals shall count as soon as they are weaned, and when they have been tested after birth, but before weaning. Birds count as soon as the egg is abandoned. Reptiles, amphibians and fish: adult animals count along and at the same time, if tested: larval forms from the time they are able to feed autonomously. Column 3 does not apply to form 2c.
Column 4: Forgotten of registered licensed breeding or delivery companies/farms in the European Union (EU), including the Netherlands. Column 4 does not apply to form 2c.
Column 5 *: Forgotten from a non-registered institution (s) in the European Union (including the Netherlands). Column 5 does not apply to form 2c.
Column 6 *: Forgot an institution from the rest of Europe. Column 6 does not apply to form 2c.
Column 7 *: Other origin: in Table 2c, the number of animals born in the wild should be entered in this column.
Column 8: Dead or killed for use in test or breeding, for example because of unfitness (genotype, sex, weight, disease, etc.) or excess.
Column 9: Dead or killed after use in fok.
Column 10: Dead or killed during or during the trial.
Column 11: Dead or killed after use in test.
Column 12: Live to another registered holder of the authorisation within the EU, including the Netherlands.
Column 13: Levende animals back to owner, released or adopted. NB Adopted animals should be specified in column 17.
Column 14: Levend exported animals to other destination.
Column 15: Number of animals present at 31 December of the registration year.
Column 16: Specification of animal species.
Column 17: Specified number of released or adopted animals.
The total of columns 2 to 7 shall be equal to the sum of columns 8 to 15. At the time of the annual registration, the number of animals present on 1 January should be equal to the number of animals present at 31 December of the previous year of registration.
The data on animal experiments shall be recorded only once, and at the end of the animal test, in code numbers. It is therefore a question of experiments which have ceased in the year of registration, irrespective of the duration of the test.
The aspects of an animal test to be mentioned must be shown using the codes prescribed per question (column). One row (record) should be used per animal. If all columns contain identical codes. data from animals may be combined into a single record, as soon as one code differs, the data should be split and a new record must be filled in.
Column 1: Special animal
Code number
| A. |
Animal other than B, C and D (ordinary animal, except monkey) |
1 |
| 9 B. |
Genetically modified animal without an uncleaned (non-pathological phenotype) |
2 |
| 9 C. |
Genetically modified animal with an uncleaned (pathological phenotype) |
3 |
| D. |
Animal derived from wild fauna, except monkey |
4 |
| E. |
Animal test in the free field (biotoop) except monkey |
5 |
| F. |
Monkey FO |
6 |
| G. |
Monkey F1 |
7 |
| H. |
Monkey F2 or greater |
8 |
| J. |
Monkey, self-contained colony |
9 |
Animals which do not comply with the definitions in codes 2 to 9 shall be registered with code 1.
If the animal test has been carried out with an animal that is a carrier of a genetic modification, code 2 shall apply unless it is a species of pathological phenotype, then code 3 shall apply.
Non-genetically modified animals required for the manufacture of a genetically modified animal, such as egg donor ears, animal species, and recipient animals (surrogate mothers) shall be registered with code 1. In that case, the code number 3 must also be entered in column 9, which stands for the manufacture of a new genetically modified line.
In the case of animals acquired from wild fauna and carried out on animal testing by the holder of the authorisation, code 4 shall apply.
Animal experiments with animals in the free field (biotoop) shall be registered with a code 5. This field is field-biological research where the animal does not come into an institution.
Monkeys are not registered with codes 1 to 5.
Column 2: Species
For the codes to be used, see the explanatory notes to column 1 of the registration form 2. Animal species with an asterisk (*) must be specified in column 15 of registration form 3.
Column 3: Animal origin (place of birth) and re-use
Code
| A. |
Reused, including monkeys |
1 |
| 9 B. |
In a registered breeding or delivery company in the EU, including the Netherlands, no apes |
2 |
| 9 C. |
In an unregistered breeding or delivery company in the EU, including the Netherlands, no apes |
3 |
| D. |
In the rest of Europe, no apes |
4 |
| E. |
Born elsewhere in the world, no apes |
5 |
| F. |
In the EU, including the Netherlands, at a registered breeder, born monkeys |
6 |
| G. |
First-born monkeys in the rest of Europe |
7 |
| H. |
Monkeys born in Asia |
8 |
| I. |
Monkeys born in America |
9 |
| J. |
Monkeys born in Africa |
10 |
| K. |
Monkeys born elsewhere in the world |
11 |
Use of the same animal shall be deemed to be re-used if there is no relationship between the tests in question, or if a different animal can be used as well. Reuse is applicable to all animal species; where there is a second or more frequent use of the same animal in accordance with the definition of re-use, code 1 is completed and the place of birth should not be registered. For the uniform registration of the re-use of animals for animal testing in education, which does not cause irreparable harm to animals, it is stated that the number of operations carried out by an animal per course/practicum is considered as a single animal test registered. If an animal is used for several activities per year, it will be counted as re-use.
Codes 2 to 11 should show the place of birth of the animal. Codes 2 to 5 shall not apply to non-human primates (monkeys); codes 6 to 11 shall apply only to monkeys. The place of birth of animals raised under code 11 (monkeys born elsewhere in the world) must be further specified in column 17.
Column 4: Number of tests on animals
For each record, a number of animal experiments with the same identical codes may be recorded.
Column 5: Purpose of the test
To describe the purpose of the animal test, the following codes are to be used. The code most commonly used should be used for this purpose. If none of the codes are applicable, a code Anders/Andere/Overig (e) should be selected in the most applicable category (marked with the letters FW, TO, WV/RP, WV/QC, WV/Tox). When choosing this option, the actual objective should be set out in an annex to the registration. If an objective is to be repeated, the holder of the authorisation may indicate it. The holder of the authorisation shall be requested to provide a code for general use.
Purpose of the test
Code
| Basic scientific research | |
| FW Cancer Research |
1 |
| FW Circulation and Lymphoid Organs |
2 |
| FW Nervous System |
3 |
| FW Respiratory System |
4 |
| FW Gastrointestinal channel incl liver |
5 |
| Musculoskeleton |
6 |
| FW Immune System |
7 |
| FW Urogenitaal system |
8 |
| FW Senses |
9 |
| FW Endocrinology and metabolism |
10 |
| FW Multisystem Research |
11 |
| FW Ethology, animal behaviour and animal biology |
12 |
| FW Anders * |
13 |
| Applied and conversion-oriented research | |
| TO Cancer in humans |
20 |
| TO Infectious diseases in humans |
21 |
| TO Cardiovascular disorders in humans |
22 |
| TO Disorders of the CNS in humans |
23 |
| TO Respiratory diseases in humans |
24 |
| TO Gastrointestinal disorders in the human, incl. liver |
25 |
| TO Musculoskeletal disorders in humans |
26 |
| TO repellents in humans |
27 |
| TO Urogenital/reproductive disorders in humans |
28 |
| TO Sensory disorders in humans |
29 |
| TO Metabolic Disorders in humans |
30 |
| TO Other human disorders |
31 |
| TO animal diseases and disorders |
32 |
| TO animal welfare |
33 |
| TO diagnostics |
34 |
| TO Plant Diseases |
35 |
| TO Unprescribed (eco) toxicology |
36 |
| Protection of the environment | 40 |
| Protection of animal species | 41 |
| Education | 42 |
| Forensic examination | 43 |
| Fok with uncleaned uses, not used in animal experiments | 44 |
| Regulated production | |
| WV/RP Blood products |
50 |
| WV/RP Monoclonals |
51 |
| WV/RP Other * |
59 |
| Quality control | |
| WV/QC Batch Safety Testing |
60 |
| WV/QC Pyrogenicity Tests |
61 |
| WV/QC Batch Potency Testing |
62 |
| WV/QC Other QC* |
69 |
| Tox and safety tests required by legislation | 70 |
| WV/Tox Acute and Subacute, LD50, LC50 |
71 |
| WV/Tox Acute and sub-acute, other lethal methods |
72 |
| WV/Tox Acute and sub-acute, non-lethal |
73 |
| WV/Tox Skin Irritation |
74 |
| WV/Tox skin sensitization |
75 |
| WV/Tox eye irritation/corrosion |
76 |
| WV/Tox Repeated dose up to 28 days |
77 |
| WV/Tox Repeated dose 29 to 90 days |
78 |
| WV/Tox Repeated dose > 90 days |
79 |
| WV/Tox Carcinogenicity |
80 |
| WV/Tox Genotoxicity |
81 |
| WV/Tox Reproduction-toxicity |
82 |
| WV/Tox Developmental Toxicity |
83 |
| WV/Tox Neurotoxicity |
84 |
| WV/Tox Kinetics |
85 |
| WV/Tox Pharmacodynamics |
86 |
| WV/Tox Phototoxicity |
87 |
| WV/Tox/Eco Acute Toxicity |
88 |
| WV/Tox/Eco Chronic toxicity |
89 |
| WV/Tox/Eco Reproduction Production Toxicity |
90 |
| WV/Tox/Eco Endocrine activity |
91 |
| WV/Tox/Eco Bioaccumulation |
92 |
| WV/Tox/Eco Other * |
93 |
| WV/Tox Safety testing food and feed |
94 |
| WV/Tox Target animal safety |
95 |
| WV/Tox Other * |
99 |
Column 6: Specification other purpose
Where licence holders opt for an Andere*/Other * objective, a description shall be given of the actual objective. The Minister may decide to award a code for this purpose in this column, which will be available for use in the next year of registration.
Column 7: Legal provisions
Code
| A. No statutory provision that required you or your client to carry out the test |
1 |
| You or your contractor was required to carry out the test on the basis of: |
|
| B. Legislation to enforce EU rules |
2 |
| C. Law only to enforce national rules (in the EU) |
3 |
| D. Legislation restricted to enforcement of non-EU rules |
4 |
It is necessary to specify the legislation to be complied with, taking into account the widest possible harmonisation level. Codes 2 to 4 can only be combined with target codes from categories WV/RP, WV/QC and WV/Tox.
Column 8: Toxicity studies and other statutory safety investigations
Code
| No Tox/WV Research |
1 |
| Tox/WV Medicinal products for humans |
2 |
| Tox/WV Animal medicines and residues thereof |
3 |
| Tox/WV Medical applications |
4 |
| Tox/WV Industrial chemicals |
5 |
| Tox/WV Plant protective products |
6 |
| Tox/WV Biocides |
7 |
| Tox/WV Power incl. contact materials |
8 |
| Tox/WV Animal Nutrition |
9 |
| Tox/WV Cosmetics |
10 |
| Tox/WV Other * |
11 |
If, in addition to the reply to column 5, there is a toxicity and other safety investigation required under legislation (category with WV/Tox), this column shall indicate which category is most applicable to of the intended main use of the substance under investigation. Codes 2 to 11 are possible only in combination with WV/Tox-objectives. In the case of the choice of code 11, the actual application should be expressed in column 17. If an application has been repeated before, the holder of the authorisation may indicate this, with a request for a code for general use.
Column 9: Special techniques
Code
| A. One of the following techniques or procedures |
1 |
| B. The killing of the animal without prior action |
2 |
| C. Grips/techniques for the manufacture of a genetically modified line |
3 |
Code 2 shall be applied where the test consists solely of killing the animal correctly in order to obtain biological material. Therefore, this technique can only be registered as the code for anaesthesia in column 10 = 1 (not applied), and for pain management in column 11 = 1 (not applied) and the code for uncleaned column 12 = 1 (light inconvenience) and code for the Condition after test in column 13 = 1 (dead or killed during or as part of the test). Otherwise, there may be a prior act.
Column 10: Anesthesia
Code Code
| A. Not applied because there was no reason to do so |
1 |
| B. Not applied as this was incompatible with the trial or was practically impracticable |
2 |
| C. Is applied |
3 |
Anaesthesia means the application of general or local anaesthesia. Both include pain management at the time of surgery. Pain management that should be recorded in the control of napin or long-term pain should be recorded in column 11.
Code 2 is used if there is any act which in itself caused pain or other inconvenience and where anaesthesia was indicated, but where anaesthesia was not applied as this was incompatible with the test or practical was impracticable.
Column 11: Pins control
Pain management, post-operative or otherwise,
Code
| A. |
Not applied as no reason for doing so |
1 |
| 9 B. |
Has not been applied as this was incompatible with the test and was practically impracticable |
2 |
| 9 C. |
Has been applied |
3 |
Pain management is not meant to be a sensitive block at the time of surgery; this is recorded in column 10. Only pain relief that should be recorded for the control of napin or long-term pain should be recorded in column 11.
Code 2 is used if there was any act that caused pain in itself and where pain management was indicated, but with no pain control applied as this was incompatible with the test or practical was impracticable.
Column 12: Degree of uncleaned
The animal has, as a result of the test, been subject to the following level of inconvenience
Code
| A. Terminals |
1 |
| B. Light |
2 |
| C. Matig |
3 |
| D. Severe |
4 |
| E. Severe overrising |
5 |
If the test consists only of an act in which the animal is kept under general anaesthesia and is killed (without being involved), code 1 shall be used.
In this column, please specify the cumulative level of uncleaned, taking into account the severity and duration of the uncleaned, uncleaned within the animal test, and measures to combat uncleaned. In the case of a special technique, code 2 (column 9, Doden without prior action), you must always use code 2 (slightly uncleaned) in column 12.
If the severity of the procedure exceeded that of the category of 'serious' whether prior to being permitted or not, no less than 5 (severe excess inconvenience) is to be chosen. In an annex to be added to the registration, referring to the record number concerned, the CHD of the NVWA should be notified which circumstances have led to very serious inconvenience.
Column 13: Condition of the animal after completion of the test
Code
| A. |
The animal has died or been killed during or at the end of the test |
1 |
| 9 B. |
The animal was left alive on completion of the test |
2 |
Animals killed in the framework, during, as a result of, or as a result of the termination of an animal test shall be registered with code 1. These include animals that have been killed without any prior action. It shall also include the animals which are subject to pathological examination at the end of the test.
Column 14: Project permit/research plan/protocol
Indicate code or number of project permit or study plan.
Column 15: Specification of other animal species
The animals referred to in a * must be indicated as the appropriate species. In this column you will need to display the Dutch and scientific name.
Animal species
Code
| Other rodents Rodentia ) * |
9 |
| Other predators (including Carnivora ) * |
29 |
| Non-human primates (other than species) Ceboidea and Cercopithecoidea ) * |
39 |
| Other mammals Mammalia ) * |
49 |
| Other Birds (other Aves) * |
59 |
| Reptiles ( Reptilia ) * |
69 |
| Other amphibians Amphibia ) * |
79 |
| Other fish (including Pisces ) * |
89 |
Column 16: Specification of other POB monkeys
Here you need to indicate what is the birthplace of apes, if you have chosen code 11 in column 3 (monkeys born elsewhere in the world).
Column 17: Specification of other Tox research
Where licence holders are selected in column 8 for code 11, a description shall be given of the actual application of the substance of the test. The Minister may decide to assign a code for this application in this column, which will be available for general use in the next year of registration.
On the basis of Article 54 (1) of Directive 2010/63 /EU and the related Articles and Annex I of Implementing Decision 2012/707, the holders of authorisations for the year of reporting 2018 and thereafter according to a five-year cycle, or in exceptional cases, on the full five-year period will be period, broken down by year requested to provide further information on specific events. This information will be requested by means of a Form 4 issued with the MAHs and NC.
This concerns the taking of tissue samples from genetically altered animals (Articles 4, 30 and 38 of the Annex). Directive 2010/63 (/EU), representative data on the approximate numbers, animal species, types of methods and the related severity of the interventions for the taking of tissue samples for genetic characterisation, carried out with or without a project authorisation.
