Dangerous drugs (Schedules II, III & IV)

Member: 

Basic information

1

Outline of the system

The Pharmacy Board is the regulatory body under the Pharmacy Act solely responsible for the issue of a licence/permit.

All medicines and pharmaceutical products must be registered with the Pharmacy Board prior to import and marketing in the country.

In addition, a certain specific category of medicines and pharmaceutical products as well as chemicals require a licence for their import. These include dangerous drugs as defined under Section 3 of the Dangerous Drugs Act 2000.

2

Product coverage

As regards to dangerous drugs, it is mandatory under the International Conventions that a permit be issued by the regulatory authority for the import/export of substances listed in Schedules II and III of the Dangerous Drugs Act 2000.

The substances listed in Schedule IV of the Dangerous Drugs Act 2000 are used in the manufacture of narcotic drugs and psychotropic substances as classified by the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, or otherwise, are included as precursors in Schedule IV.

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

Dangerous drugs are subject to regulatory control under the International Convention to prevent illicit trafficking and diversion to ensure that importation is for bona fide purpose.

6

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

Import of Schedules II, III and IV dangerous drugs are, subject to a yearly quota which is established as follows: Please see Answers 6.1-6.11.

7

The system applies to products originating from which country?

The licensing system applies to goods coming from all countries

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?

Pharmaceutical products can only be imported by registered wholesale pharmacies under the supervision of pharmacists.

13

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

14

Is there a registration fee?

15

Is there a published list of authorized importers?

A list of registered pharmaceutical wholesalers is available at the Ministry of Health and Wellness.

Contact point for information on eligibility

16

Ministry/Authority

17

Address

18

Telephone

19

Fax

20

E-mail address

21

Website

22

Contact officer

Submission of an application

23

Administrative body(ies) for submission of an application

Pharmacy Board, Ministry of Health and Wellness

Documentation requirements

24

What information is required in applications?

The applicant is required to submit the required information as per international procedures as recommended by WHO

25

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

The applicant is required to submit the required information as per international procedures as recommended by WHO

Window of submission of an application

26

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

N/A.

27

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

N/A.

Issuing the license

28

Can a licence be granted immediately on request?

N/A.

29

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

N/A.

30

Which administrative body is responsible for approving application of licences?

N/A.

31

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

N/A.

32

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

For dangerous drugs (Precursor Chemicals) (Schedule IV), the procedure for the issue of permit/certificate follows the same pathway as for schedule II and III dangerous drugs except that the authority in the exporting country will issue a Pre- Export Notification (PEN) certificate requesting for confirmation from the authority of the importing country on the authenticity of the import prior to shipment. There are no such conditions that licences are issued exclusively for export only.

Fees and other administrative charges

33

Is there any licensing fee or administrative charge?

A processing fee of MUR 2,500 and a registration fee of MUR 5,000 per product (non-refundable).

34

What is the amount of the fee or charge?

Fees are also applicable for extension in line and variations of imported pharmaceutical products as follows :

- Change in shelf life 2,000 MUR
- Change in manufacturing site/distribution channel 2,000 MUR
- Extension in line of product 2,000 MUR
- Change in trade name 2,000 MUR
- Change in /additional pack size 1,000 MUR
- Change in pack design (primary pack) 1,000 MUR
- Change in design secondary pack) 1,000 MUR
- Change in packing material 1,000 MUR
- Change in label design 1,000 MUR

35

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

No deposit.

36

Amount or rate?

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Is it refundable?

38

What is the period of retention?

39

What is the purpose of this requirement?

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 clearance may be refused in the case of importation of pharmaceutical products including dangerous drugs (Schedules II, III and IV), if the applicant is not a registered importer.

41

Are the reasons for any refusal given to applicants?

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?

45

What documents are required upon actual importation?

A copy of the import licence must be submitted along with the invoice.

46

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

No.

Conditions of licensing

47

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

The validity of a licence for pharmaceutical products is subject to renewable every year, upon payment of MUR 2,000.

48

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

There is no penalty for the non-utilisation of licence.

49

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

The licence is 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 by the banking authorities for goods to be imported.

51

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

52

Is foreign exchange always available to cover licences issued?

53

What formalities must be fulfilled for obtaining the foreign exchange?

The following questions are only for products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally)

6.1

Where is information on allocation and formalities for licences published? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?

At the end of every year, pharmaceutical wholesalers are required to submit a return of their transactions indicating opening stock, quantity purchased and sold during the current year and balance in hand.

6.2

Is the size of the quota determined: on yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for a fresh licence on a six-monthly or quarterly basis?

They are also required to submit their request in respect of their requirements for the subsequent year. Quota is worked out on the basis of the data submitted. Adjustments, if any, to the quota are effected in the course of the year, however, full justifications must be provided.

6.3

Are licences allocated for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate)

The requirement at national level is worked out and submitted to the International Narcotics Control Board (INCB) in Vienna for the establishment of national quota especially for dangerous drugs Schedule II (narcotics) which, are recorded and published. Unused quotas cannot be carried forward for a succeeding year.

6.4

From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?

Once a quota is established, the issue of the import permit/certificate is effected within a couple of days of submission of request. The importer will have to forward a copy of the import permit/ certificate to the exporter who will forward a copy of same to the authority in the exporting country in view of obtaining an export licence to enable shipment of the consignment of the dangerous drugs.
Similarly, in the case of Schedule IV dangerous drugs (Precursor Chemicals), issue of a licence may be refused if it is suspected that the import of the chemicals is not for legitimate use. There is no right of appeal in the event of a refusal of a licence.

The application must be submitted at the beginning of the year when the yearly quota has been allocated. However, import may be effected in a staggered manner during the year.

6.5

What are the minimum and maximum lengths of time for processing applications?

6.6

How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?

6.7

Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?

6.8

If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?

6.9

In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?

6.10

In cases where imports are allocated on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?

6.11

Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?