Medicinal products

Basic information

1

Outline of the system

Most goods enter the Republic of Moldova without an import license, with the exceptions of those specified in the national legislation. However, certain goods which may affect the health of citizens or raise environmental or national security concerns, require a licence / permission to be imported into the country. The licenses do not establish any limitations on the quantities of goods.

2

Product coverage

The import of the following products is subject to licence/permission in Republic of Moldova:
l. import of medicinal products.

Nature of licensing

Automatic

3

If Automatic, administrative purpose

Non-Automatic

4

If Non-Automatic, description of the notified Non-Automatic Licensing regime

5

Products under restriction as to the quantity or value of imports

The license and permission requirements do not include any quantitative or value restrictions. It is designed to provide up-to-date information on trade in commodities of social or security concern. Licensing is believed to be the least costly way of securing such information.

6

Questions for products under restriction as to the quantity or value of imports

Goods imported under import licensing/permission procedures are not subject to restriction as to the quantity or value of imports.

7

The system applies to products originating from which country?

The licenses and permissions apply to any product imported from any country, and products originating in any country.

8

Expected duration of licensing procedure

Eligibility of applicants

12

Is there a system of registration of persons or firms permitted to engage in importation?

13

What persons or firms are eligible to apply for a licence?

All legal persons are equally eligible to apply for import licences/permission.

14

Is there a registration fee?

15

Is there a published list of authorized importers?

Contact point for information on eligibility

16

Ministry/Authority

Ministry of Health

17

Address

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Telephone

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Fax

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E-mail address

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Website

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Contact officer

Submission of an application

23

Administrative body(ies) for submission of an application

In the case of (l) the permission on importation is granted by the Medicines Agency.

Documentation requirements

24

What information is required in applications?

The application for import of certain products has to provide the following information:

(a) Declaration of the model established by the respective authority, signed by the person making the declaration, containing:
• name, legal form of organization, location, company or organization IDNO; name, address and IDNP of the individual;
• type of activity, full or partial, for which the license applicant intends to obtain a license;
• assuming the responsibility for complying with license conditions to conduct the type of activity for which the license for the authenticity of submitted documents.

25

What documents is the importer required to supply with the application?

(b) Declaration for issuing the license is accompanied by the following documents:
• copy of certificate of state registration of the enterprise or organization or the ID of the individual;
• Additional documents in accordance with the legislative acts regulating the licensed activity of the requested license;

In order to obtain the permissive act, the applicant must submit to the issuing authority, personally, by recommended letter or by e-mail the necessary documents required by the legislative act that regulates the respective activity or an application accompanied by an affidavit on compliance requirements of legal acts regulating activities for which require permissive act.

Window of submission of an application

26

How far in advance of importation must application for a licence be made?

An applicant for an import licence/permission may submit an application at any time.

27

Are there any limitations as to the period of the year during which application for licence can be made? If so, explain

A licence/permission is issued for the period stipulated by the Law. There is no minimum time frame between the date of the issuance of the licence/permission and the date by which the importation must occur. Procedures do not vary according to the period of the year.

Issuing the license

28

Can a licence be granted immediately on request?

There is no defined shorter time-limit, but the legislation provides that if no reasonable rejection is given within a predetermined time limit, the license/permission is deemed issued by the issuing authority.

29

Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence

The decision to issue a licence, or to refuse one, is made within 5 working days from the date of the presentation of all the necessary documents and respectively within 10 working days to issue or refuse a permission.

30

Which administrative body is responsible for approving application of licences?

Generally, consideration of application for import licence is effected by only one administrative body, Licensing Chamber.

31

Must the applications be passed on to other organs for visa, note or approval?

In case of the permission consideration of permission applications is carried out by the respective issuing body.

32

Are there any other conditions attached to the issue of a licence?

There are no other conditions attached to the issue of license/permissions.

Fees and other administrative charges

33

Is there any licensing fee or administrative charge?

There is a one-time mandatory fee for obtaining the licence aiming to cover the administrative expenses. The amount for the licence fee is determined in conformity with Article 18 of Law No. 451-XV of 30 July 2001 on Business Activity Licensing.

34

What is the amount of the fee or charge?

The amount for the permission fee is expressly specified in the Nomenclature of Permits

35

Is there any deposit or advance payment required associated with the issue of licences?

There is no other deposit or advance payment except that paid for licensing/permission fee.

36

Amount or rate?

There is no other deposit or advance payment except that paid for licensing/permission fee.

37

Is it refundable?

There is no other deposit or advance payment except that paid for licensing/permission fee.

38

What is the period of retention?

There is no other deposit or advance payment except that paid for licensing/permission fee.

39

What is the purpose of this requirement?

There is no other deposit or advance payment except that paid for licensing/permission fee.

Refusal of an application

40

Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?

An application for an import licence/permission may be refused if any of the requirements set forth in the legislation is not met.

41

Are the reasons for any refusal given to applicants?

The reasons for refusal must be provided in writing to the applicant.

42

Have applicants a right of appeal in the event of refusal to issue a licence?

43

If so, to what bodies and under what procedures?

Importation

44

Are there any limitations as to the period of year during which importation may be made?

A licence/permission is issued for the period stipulated by the Law. There is no minimum time frame between the date of the issuance of the licence/permission and the date by which the importation must occur. Procedures do not vary according to the period of the year.

45

What documents are required upon actual importation?

Upon actual importation the following documents are required:

• Import licence/permission
• Commercial invoice
• Sale Purchase Contract
• Annex (specification) to the sales contract

46

Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

No other administrative procedures are required.

Conditions of licensing

47

What is the period of validity of a licence? Can the validity be extended? How?

In general the permission is issued for an unlimited time period, as well as for defined time period, stipulated by Law. The validity of the licence varies from 1 to 5 year, according to the type of the licence required. The validity of the licence/permission can be extended, but not after the term of validity of the economic agreement, which refers to this licence/permission.

48

Is there any penalty for the non-utilization of a licence or a portion of a licence?

There are no penalties for the non-utilization of a licence/permission. If a licence/permission is not utilized, it is cancelled and returned to the issuing institution.

49

Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Licences/permissions are not transferable between importers.

Foreign Exchange

50

Is foreign exchange automatically provided by the banking authorities for goods to be imported?

Foreign exchange is automatically provided through the banking system for goods to be imported.

51

Is a licence required as a condition to obtaining foreign exchange?

A licence/permission is not required as a condition to obtain foreign exchange.

52

Is foreign exchange always available to cover licences issued?

Foreign exchange is always available to cover licences/permissions issued.

53

What formalities must be fulfilled for obtaining the foreign exchange?

The only formality to be performed in order to obtain foreign exchange is to present the import contract indicating the amount to be paid for imported goods.