ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of August 19, 2014 No. 674

About functioning of single window for issue of allowing documents in the field of drugs

Based on part 4 of article 7 of the Law No. 161 of July 22, 2011 on implementation of single window in implementation of business activity (The official monitor of the Republic of Moldova, 2011, Art. No. 170-175, 496), the Law No. 160 of July 22, 2011 on regulation of business activity by permission (The official monitor of the Republic of Moldova, 2011, Art. No. 170-175, 494), with subsequent changes and amendments, DECIDES: the Government

1. Approve:

Regulations on functioning of single window for issue of allowing documents in the field of drugs, according to appendix No. 1;

changes and additions which are made to appendices No. 1 and 3 to the Order of the Government No. 778 of October 4, 2013, according to appendix No. 2.

2. To perform financial provision of activities of single window of the Agency for drugs and medical products for issue of allowing documents in the field of drugs for the account and within the assignments approved in the budget of the Agency.

3. To impose control over the implementation of this resolution on the Ministry of Health.

Appendix № 1

to the Order of the Government of the Republic of Moldova of August 19, 2014 No. 674

Regulations on functioning of single window for issue of allowing documents in the field of drugs

Chapter I. General provisions

1. The regulations on functioning of single window for issue of allowing documents in the field of drugs (further – the Provision) are developed for the purpose of increase in efficiency of obtaining and confirmation of provided information, and also procedure for issue of allowing documents in the field of drugs to physical persons and legal entities for implementation of business activity in the field of drugs.

2. The agency on drugs and medical products (further – the Agency) is the body authorized by the rights for issue through single window of allowing documents in the field of drugs according to appendix to this provision.

3. The single window for issue of allowing documents in the field of drugs (further – single window) is the single platform of the national level allowing the applicant to address through one collection point public body authorized to provide all process of consideration of information after receipt of the documents provided by the applicant, for the purpose of issue of the allowing document.

4. The agency equipped with functions of consideration, coordinating, approval and issue of documents will provide consideration through single window of the submitted documents, according to the functional obligations provided by the Order of the Government No. 71 of January 23, 2013 "About approval of the Regulations on the organization and functioning, structure and limiting manpower ceiling of the Agency on drugs and medical products".

5. For the services rendered through single window, the payment is not levied.

Chapter II. Functions of single window

6. The single window performs the following functions:

1) provides consultations to the physical persons and legal entities which are engaged in business activity in the field of drugs and informs applicants on the procedure of giving and reception of applications about documents which need to be provided, on terms of their consideration, the procedure of issue/receipt of necessary allowing documents;

2) adopts statements from applicants with the enclosed documents, according to provisions of the current legislation;

3) provides check of correctness and completeness of statements and the submitted documents;

4) also legality of acts and the submitted documents verifies authenticity;

5) provides transfer of the adopted acts to divisions of the Agency involved in process of consideration of the documents submitted by the applicant;

6) provides processing and placement of information on the web page of the Agency;

7) issues authorizations, certificates and bulletins of the analysis;

8) creates and keeps registers of allowing documents.

7. The single window issues the allowing documents specified in appendix to this Provision.

Chapter III. Organization of activities of single window

8. The single window is placed in the Agency, allocated for these purposes.

9. Activities of single window are organized according to the program of activities installed and provided with employees of the Agency.

Chapter IV. Giving and consideration of the application about issue of the allowing document in the field of drugs

10. The statement for issue of the allowing document in the field of drugs with the accompanying documents provided by the current legislation moves through single window on paper and/or on-line in electronic format.

11. The employee of single window checks correctness and completeness submitted statements and documents, establishes their authenticity and legality, adopts or rejects the statement.

12. In case of adoption of the statement for issue of the relevant allowing document the applicant is informed on the term of consideration of the application, and also on procedure for its notification on the made decision as a result of consideration of the application.

13. The statement will not be taken cognizance and will be rejected if:

1) the application is not signed or constituted incorrectly;

2) the incomplete set of documents is provided;

3) person has no right and legal powers to filing of application and necessary documents.

In these cases the employee of single window demands from the applicant of elimination of the revealed inaccuracies or submission of missing documents.

14. If the statement for issue of the allowing document in the field of drugs is rejected, the applicant can submit the new application after elimination of the reasons which formed the basis for variation of the former statement.

15. In case of acceptance of information, the employee of single window without fail warns the applicant about responsibility which he bears, and about sanctions in case of conscious declaring of obviously false information.

16. After adoption of the statement for issue of the allowing document and accompanying documents to the applicant the confirmatory act of filing of application and proper documents with indication of the date of receipt of information is issued.

17. The employee of single window considers the adopted statement on the same day and provides its transfer and accompanying documents to competent divisions of the Agency for consideration and decision making for the purpose of issue of the declared allowing document.

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