Rwanda FDA import permits for food, medicines and cosmetics

Who regulates imports and the legal basis

The Rwanda FDA food import guideline cites Law No 003/2018 of 09/02/2018 establishing the Rwanda Food and Drugs Authority, Law No 47/2012 of 14/01/2013 on the regulation and inspection of food and pharmaceutical products, and Regulations No FDISM/FDIEC/TRG/003 on food imports and exports ³.

Two Rwanda FDA notices from September 2024 say all applications go through its online platform, IRIMS ^1,2. Every import is physically inspected at the port of entry or at the client's premises ¹. Contacts given are import&[email protected] and 0788755822 ².

Documents needed

The notices of 6 and 14 September 2024 list three core documents ^1,2.

• A certificate of compliance for the manufacturer or supplier, such as GMP, ISO, CE, IEC or GDP, for unregistered products. Manufacturers in the EAC give a Bureau of Standards permit to use the standardisation mark ¹.
• A certificate of analysis for each lot or batch. A health or phytosanitary certificate may replace it where applicable ¹.
• A commercial invoice ^1,2.
• Extra documents for special cases: a donor certificate for donations, a clinical trial approval for investigational products and Ethics Committee clearance for research products ².
• Used medical devices must have at least 80% of their lifespan left. Documents and labels must be in an official language of Rwanda ¹.

Fees as a share of FOB value

The notice dated 6 September 2024 listed verification fees by category ¹. The later notice dated 14 September 2024 gives one rate of 0.2% FOB for import permits for regulated products, raw materials and labelling or packaging materials. It says sector-level waivers remain valid ². Neither notice states a currency ^1,2. This page has not found a statement on whether the second notice replaced the first table.

Food imports: visa, licence and inspection

The Guidelines for Importation and Exportation of Food products, revision 1, took effect on 23 December 2022 ³. They describe two steps. The import visa confirms that products from an eligible manufacturer can come in. The import licence then allows import of the approved consignment once physical inspection is satisfied ³.

The visa needs a proforma invoice, the importer's operational licence and a certificate of compliance. The licence needs the visa, a commercial invoice, a packing list if applicable, a certificate of analysis or health certificate and proof of fee payment ³. Both are valid six months, cover one consignment and cannot be transferred ³.

At the border, food with a shelf life of nine months or more must have at least six months left. Shorter-life food must have at least 80% left ³. Rejected food that is unsafe is destroyed under supervision. Other rejected products must be re-exported within one month ³.

Medicines and products in your luggage

Rwanda FDA guidelines on regulated products declared as personal effects took effect on 15 March 2023 ⁴. They allow a 90-day supply, or one course of treatment, of medicines and medical devices. Food, cosmetics and household chemicals are limited to a 90-day supply. Controlled substances are limited to 30 days ⁴.

Prescription medicines need a prescription or a letter from an authorised practitioner ⁴. Controlled drugs may be brought only by a returning resident or a visitor with a prescription from the country of origin. Buying them online or sending them by courier is not allowed ⁴.

Travellers declare on form FDISM/FDIEC/FOM/002, available at ports of entry ⁴. Medicines and medical devices for personal use are exempt from verification fees. Other personal consignments under 100 USD are exempt and those above 100 USD pay verification fees ⁴. Quantities beyond the personal limits are treated as commercial imports ⁴.