Could anyone give me a guidance on export of prescribed and unprescribed drugs from the UK

Answer

Hello,
This is a complicated area.
Firstly you will need to meet the requirements of standard exports:
You will need to establish a customs tariff code for each drug see this link:https://www.gov.uk/trade-tariff. The tariff code is a way of describing an item with just a numeric code so that it can be understood around the world even if you can’t read the written description. The tariff code also helps to determine the licences required and the amount of import duty payable at the destination.

The tariff code can also be used to work out which licences, permissions etc. are required by the importer at the destination in order that the goods can be imported. To start to look at this by finding the duty and taxes applicable and some of the import requirements take a look at this web site http://madb.europa.eu/madb/indexPubli.htm under tariffs.

You will also need to produce an invoice for export. This invoice will also be used for importation at the destination. The invoice should include the description, quantity, country of manufacture, currency and value for each item line. The value should be the value that you sold the items to the buyer.

You may need to produce a certificate of origin for the products. Depending on the tariff code this can sometimes give a reduced amount of import duty and tax. There are different types of certificate of origin. Look at the web site for the London Chamber of Commerce.

Individuals are permitted to export but if this is a business it would be better to do this as a company. You will need to get an EORI number which is a kind of registration with UK Customs.

You will also need to investigate how you wish to get the goods to destination. You will need to research which company will carry your type of items to your chosen destinations and who you want to pay the import duty and taxes – you or your customer.

This should get you started. Regards, Susan

Answer

Dear Nr Fara,

Thank you for your question.

Both the prescribed and un-prescribed drugs should be registered by the Ethiopian Food, Medicine, and Health Care Administration and Control Authority (FMHCAC) to be eligible for export into Ethiopia. The authority undertakes various tests to check the drugs for safety, quality and efficacy. The registration process is quite stringent and could take from 6 – 12 months. An applicant for registration should meet the following requirements (see attached Guidelines for the registration of human drugs to know the exact details):

Appoint at least one agent who could follow the registration process on behalf of the exporter. It is only through agents that the company could export into Ethiopia. The number of agents the company can appoint is also restricted by law to a maximum of three.

Check if the drug is already registered (included in the national drug list); please refer on the Authority website – www.fmhaca.gov.et , and submit further additional documents and samples as listed in the guideline.

New applicants are expected to submit Manufacturing Practice (GMP) certificates given by Stringent Regulatory Authorities (SRA), a complete dossier and a copy of Market Authorization issued by SRA, (see attached Market Authorization Guideline).

If the applicants have no Good Manufacturing Practice (GMP) certificates given by Stringent Regulatory Authorities (SRA), the Authority would undertake physical visits to their manufacturing facilities to determine if the factories meet its requirements.

If the drug meets all the requirements of FMHCAC, it will give 4 years market authorization for the drug to be imported into Ethiopia.

Purchase order and import permits are always required for every consignment of drugs to be exported into Ethiopia.

Posted on behalf of Dessalegne Yigzaw – UKTI Ethiopia