Disclaimer: The English language text below is provided by the Translation and Terminology Centre for information only; it confers no rights and imposes no obligations separate from those conferred or imposed by the legislation formally adopted and published. Only the latter is authentic. The original Latvian text uses masculine pronouns in the singular. The Translation and Terminology Centre uses the principle of gender-neutral language in its English translations. In addition, gender-specific Latvian nouns have been translated as gender-neutral terms, e.g. chairperson.

Republic of Latvia Cabinet Regulation No. 909 Adopted 9 November 2004

Procedures for Issuing a Certificate for Conduct of Efficiency Examination Trials of Plant Protection Products

Issued pursuant to
Section 5, Clause 9
of the Plant Protection Law

I. General Provisions

1. These Regulations prescribe the procedures following which the State Plant Protection Service (hereinafter - the Service) shall issue a certificate (Annex 1) regarding the rights to perform trials of efficiency examinations specified in regulatory enactments regarding the registration of plant protection products (hereinafter - trial).

2. A decision regarding the issuance of a certificate shall be taken for each type of trial separately. A place of the trial, a group of cultivated plants and a usuage category of a plant protection product shall be indicated in the certificate.

3. The period of validity of a certificate shall be five years.

4. The Service shall:

4.1. publish information regarding the certificates issued, re-issued, cancelled, and regarding the suspension and renewal of certificate operation in the newspaper "Latvijas Vēstnesis" [the official Gazette of the Government of Latvia]; and

4.2. inform the European Union Member States regarding the issued certificates.

II. Issuing of a Certificate

5. Such performer of trials may apply for a certificate, who:

5.1. has been registered in the Commercial Register;

5.2. complies with the work quality requirements specified in regulatory enactments regarding the registration of plant protection products (hereinafter - work quality requirements); and

5.3. performs trials, research and tests, and drafts reports in accordance with the methods and standards specified in regulatory enactments regarding the registration of plant protection products.

6. In order to receive a certificate, a performer of trials shall submit to the Service the following documents:

6.1. a submission (Annex 2);

6.2. a copy of the merchant registration certificate (upon presenting the original); and

6.3. after completion of trials - a report regarding each type of the trials indicated in the submission.

7. Within a period of one month from the day the documents referred to in Sub-paragraphs 6.1 and 6.2 of these Regulations are received the Service shall evaluate them and take a decision regarding the initiation of conformity assessment, or, if the referred to documents have not been submitted, or the information therein is incomplete, the time for submission of the relevant documents shall be determined.

8. The Service shall co-ordinate the time of conformity assessment with the performer of trials, and evaluate:

8.1. the compliance of the information indicated in the submitted documents with the actual information;

8.2. the compliance of the performer of trials with the work quality requirements; and

8.3. the compliance of the performed trials, research and tests with the requirements specified in Sub-paragraph 5.3 of these Regulations (for each type of trials indicated in a submission).

9. The term for compliance assessment shall be the time period necessary for the performance of a trial (from the beginning of planning until the completion of the trial).

10. Within a period of one month after the receipt of the report referred to in Sub-paragraph 6.3 of these Regulations, on the basis of the results of the assessment referred to in Paragraph 8 of these Regulations, the Service shall take a decision:

10.1. regarding the issuance of a certificate - if a performer of trials complies with the requirements referred to in Paragraph 5 of these Regulations;

10.2. regarding the refusal to issue the certificate - if the performer of trials does not comply with any of the requirements referred to in Paragraph 5 of these Regulations; or

10.3. regarding the determination of a term for the elimination of a deficiency detected during an assessment - if the elimination of the relevant deficiency is possible.

11. If a performer of trials has not eliminated deficiencies within the term specified by the Service or has not submitted documents within the term referred to in Paragraph 7 of these Regulations, the Service shall take a decision to refuse to issue a certificate.

III. Re-issuing of a Certificate

12. If a performer of trials wishes to receive a certificate again, he or she shall submit the documents referred to in Paragraph 6 of these Regulations to the Service at least six months prior to the certificate expiration date.

13. The Service shall take a decision regarding a re-issuance of a certificate in accordance with Paragraphs 6, 7, 8, 9, 10 and 11 of these Regulations.

IV. Duties and Supervision of a Certificate Holder

14. A certificate holder shall submit to the Service:

14.1. within a period of three working days - information regarding changes in the contact information (address, telephone number, the responsible persons, employees);

14.2. annually by 15 May - information regarding the organisational structure, staff, premises, equipment, trial areas and descriptions of activities;

14.3. annually by 15 June - information regarding trials initiated in spring, indicating the number, name and location of the trial;

14.4. annually by 15 November - information regarding trials initiated in autumn, indicating the number, name and location of the trial; and

14.5. annually by 31 December - a list of trials performed, indicating the number, name and place of the trial;

15. The Service shall co-ordinate the time of an examination with a certificate holder and examine the compliance thereof with the requirements referred to in Paragraph 5 of these Regulations by performing:

15.1. random examinations once a year; and

15.2. overall examinations once every three years.

16. The Service shall draw up an examination statement regarding the performed examination and, if necessary, provide instructions regarding the improvements or changes necessary in the performance of trials.

V. Suspension, Renewal and Cancellation of Certificate Operation

17. The Service is entitled to take a decision regarding the suspension of a certificate operation for a time period of up to six months if:

17.1. in performing the examination referred to in Sub-paragraphs 15.1 or 15.2 of these Regulations, the Service determines that the performance of trials does not comply with the requirements referred to in Paragraph 5 of these Regulations and the determined non-compliance has an impact on the trial results. In taking the decision regarding the suspension of the certificate operation, the Service shall determine a term for the elimination of deficiencies; or

17.2. a submission of the certificate holder regarding the suspension of the certificate operation has been received.

18. The Service shall take a decision regarding the renewal of the term of a certificate operation if:

18.1. a certificate holder has eliminated the deficiencies referred to in Sub-paragraph 17.1 of these Regulations and complies with the requirements referred to in Paragraph 5 of these Regulations; or

18.2. the operation of a certificate has been suspended in accordance with Sub-paragraph 17.2 of these Regulations and a submission of the certificate holder regarding the renewal of the term of operation has been received.

19. In renewing the term of certificate operation, the validity period of a certificate shall remain.

20. The Service shall take a decision regarding the cancellation of a certificate if a certificate holder:

20.1. does not comply with the requirements referred to in Sub-paragraph 5.2 of these Regulations and it is not possible to eliminate the detected deficiencies;

20.2. cannot perform trials, research and tests in accordance with the requirements referred to in Sub-paragraph 5.3 of these Regulations;

20.3. has not eliminated the deficiencies referred to in Paragraph 17.1 of these Regulations within the time period determined by the Service; or

20.4. submits a submission regarding the cancellation of the certificate.

VI. Closing Provision

21. A person who has not received a certificate for performance of trials may conduct trials for the registration of a plant protection product up to 31 December 2005.

Informative Reference to European Union Directives

These Regulations contain legal norms arising from the Commission Directive 93/71/EEC of 27 July 1993, amending the Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

Prime Minister I. Emsis

Minister for Agriculture M. Roze

 

Annex 1
Cabinet Regulation No. 909
9 November 2004

Certificate No. ________

Issued to
	(firm name of merchant, registration number, legal address)

with the right to perform efficiency examination trials specified in regulatory enactments regarding the registration of plant protection products:

(place of a trial, group of cultivated plants, the usuage category of a plant protection product)

Certificate issued on
	(date)
Certificate valid until
	(date)

Official
	(position, signature and full name)

Seal

Minister for Agriculture M. Roze

 

Annex 2
Cabinet Regulation No. 909
9 November 2004

Submission for the Receipt of a Certificate

I request to issue a certificate with the right to perform efficiency examination trials specified in regulatory enactments regarding the registration of plant protection products:

1. Submitter (name or given name, surname)

Telephone

Fax

E-mail

Address

2. Type of trial (indicate the place of the intended trial, the group of cultivated plants and the usuage category of the plant protection product in the relevant shaded sections of the table: I - insecticides, H - herbicides, F - fungicides, K - stains, AR - plant growing controllers; if other - indicate)

Place of trial	Group of cultivated plants		Group of cultivated plants		Group of cultivated plants		Group of cultivated plants		Group of cultivated plants
Field	Cereal crops		Potatoes		Sugar beet		Forage crop		Vegetables
Greenhouse	Vegetables		Decorative plants		1
Fruit plants	Fruit trees		Berry bushes		Strawberries		1
Forest	Stands		Nurseries		Decorative woody plants		1
Storage facility	Plant products		1

Note. ¹ Indicate if other object.

3. Information attached to the submission describing the performer of trials

3.1.	organisational structure
3.2.	scientific and technical staff
3.3.	work space, laboratories, warehouses
3.4.	trial areas, fields, greenhouses
3.5.	technical means, installations
3.6.	trial file and sample report
3.7.	description of standard operating procedures

We certify that all the information provided in the submission is complete and true.

(date)		(signature and full name of the submitter)

Seal

An Explanation for the Completion of a Submission

1. Information regarding the submitter

The responsible person completes and signs the submission.

2. Type of trial

The intended types of trials shall be indicated in the submission, indicating the place of trial, group of cultivated plants and the usuage category of the plant protection product.

3. Information attached to the submission, describing the performer of the trial:

3.1. organisational structure - provide information (in a form of a chart) regarding the organisational structure and the division of duties, give an overview of the planned trial groups (if applicable);

3.2. scientific and technical staff - provide an overview of the employed staff, auxiliary staff and duties of each employee, attach the CVs of the employees, as well as documents certifying the education, technical knowledge, skills and the experience thereof;

3.3. work space, laboratories, and warehouses - submit a layout of premises, indicating the size and arrangement thereof, as well as describing the suitability thereof for the needs of the trial;

3.4. trial areas, fields, greenhouses - provide information regarding the owner of the trial area and a copy of the contract regarding the performance of trials (if the performer of trials does not own the trial area). Submit a map on which the trial area and the arrangement of fields is indicated, as well as provide information regarding the location, size, agronomic description (agro-chemical indicators of the soil, history of the field for the last three years), the placement in terrain and suitability for trials;

3.5. technical means, installations - provide a list of those installations and other technical means, which are used in the preparation of trials (for example, pickling machinery, sowers), cultivation, treatment (for example, sprayers), harvesting (for example, combine harvester), recording of a harvest (for example, scales, moisture meter), and harvest analysis (for example, grain counters). Indicate only such equipment, which requires regular servicing and calibration. The installations referred to in the documentation attached to the submission must correspond to the installations described in the activity procedure descriptions. Indicate the number of the activity procedure description, in which the installation or technical means are described;

3.6. trial file and sample report - submit a completed trial file (for example, trial plan, minutes, accounting forms) and a sample report for all the types of trials indicated in the submission; and

3.7. standard operating procedures (drafted in accordance with the recommendations of the State Plant Protection Service) - submit a list of the completed standard operating procedures and attach a list of the planned standard operating procedures (if available). Prepare standard operating procedures for all the activities necessary for the performance of trials, beginning with the preparation of seed material and field admeasurement and ending with the data processing and drafting of the report.

Minister for Agriculture M. Roze

 

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