Antibiotics, vaccines and therapeutic substances and, dangerous drugs (Schedule I)

Member: 

Basic information

1

Outline of the system

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

In addition, certain specific category of medicines and pharmaceutical products as well as chemicals require a licence for their import. These include:

• Antibiotics, vaccines and any therapeutic substance

• Schedule I, dangerous drugs

The substances listed in Schedule I of the Dangerous Drugs Act are only meant for the use of Forensic Science Services in quantities not exceeding those strictly requested for the purpose in question. They are not subject to any quota.

2

Product coverage

For each consignment of an antibiotic, vaccine and a therapeutic substance, imported, the importer (Pharmaceutical Wholesaler) is required to submit an application for a permit as specified under Section 25 of the Pharmacy Act indicating the name of the product(s) and quantity in respect of each product being imported. An import permit is then delivered to the importer accordingly.

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

Nature of licensing

Automatic

3

If Automatic, administrative purpose

Non-Automatic

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

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Products under restriction as to the quantity or value of imports

The licensing process is intended to exercise control over import as per international requirements to ensure that the goods are destined for legitimate use (medicinal, scientific, and educational). They are also subject to regulatory control under the International Convention to prevent illicit trafficking and diversion to ensure that importation is for bona fide purposes.

6

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

N/A.

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The system applies to products originating from which country?

The licensing system applies to goods coming from 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?

Any person, firm or institution is eligible to apply for licences. Issue of licence is applicable to both importers and producers of goods. Pharmaceutical wholesalers are registered entities with the Pharmacy Board. They also hold a trading licence from the local authorities. Similarly, the importers or dealers involved in the trade of chemicals need to be licenced by the local authorities.

14

Is there a registration fee?

15

Is there a published list of authorized importers?

Contact point for information on eligibility

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Ministry/Authority

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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

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Administrative body(ies) for submission of an application

Pharmacy Board, Ministry of Health and Wellness

Documentation requirements

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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?

It is advisable to apply for the permit/licence prior to import.

27

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

There is no time limit for submitting an application for permit /licence in the case of therapeutic substances including antibiotics and vaccines, as well as for chemicals and substances listed in Schedule I of the Dangerous Drugs Act. An application can be submitted any time an import is to be effected during the year.

Issuing the license

28

Can a licence be granted immediately on request?

Licence/permit may be issued immediately upon request and at time when goods have arrived at the port only in the case of therapeutic substances including antibiotics and vaccines, on a consignment basis.

For Schedule I dangerous drugs, an import licence/permit is issued within a couple of days of submission of request.

29

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

Licence/permit may be issued immediately upon request and at time when goods have arrived at the port only in the case of therapeutic substances including antibiotics and vaccines. However, it is advisable to apply for the permit/licence/certificate prior to import.

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Which administrative body is responsible for approving application of licences?

31

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

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

The issue of a licence is subject to any additional information or clarification that maybe required in respect of same.

For Schedule I, dangerous drugs, 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.

Fees and other administrative charges

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Is there any licensing fee or administrative charge?

A processing fee and a registration fee

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What is the amount of the fee or charge?

A processing fee of MUR 1,500 and a registration fee of MUR 5,000 per product (non -refundable).

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

No deposit.

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Amount or rate?

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Is it refundable?

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What is the period of retention?

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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 licence/permit may be refused in the case of importation of pharmaceutical products including Schedule I, dangerous drugs if the applicant is not a registered pharmaceutical wholesaler, laboratory or an educational institution.

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Are the reasons for any refusal given to applicants?

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

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If so, to what bodies and under what procedures?

Importation

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

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What documents are required upon actual importation?

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

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

All pharmaceutical products are required to be registered by the Pharmacy Board prior to import and marketing in Mauritius.

Conditions of licensing

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

(i) The validity of the licence for import of schedule I, dangerous drugs and chemicals is three months from the date of issue. It may be extended upon request if there is a delay in supply.
(ii) As regards import permit for vaccines, antibiotics, etc. the permit is issued on consignment basis at time of arrival of the goods.

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?