“No FARMIN certificate”: what it is and when it is needed

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The NO FARMIN certificate is a document that certifies that the imported goods are not classified as pharmaceutical products under Law 14/1986. It is mandatory to complete and present it at Customs for any import from third countries.

Regardless of the type of goods imported, the importer must justify that the products do not fall under the references listed in Regulation (EC) 765/2008 of the European Parliament and the Council on accreditation and market surveillance for product commercialization or, on the contrary, that they are listed.

The Spanish Agency for Medicines and Health Products (AEMPS) controls the importation of regulated products according to the regulations approved by the European Parliament. Goods intended for pharmaceutical use must undergo inspections to verify their quality

The only difference lies in the type of document to be presented in each situation. The NO FARMIN certificate, to justify that the imported goods will not be used for pharmaceutical purposes, consists of a customs authorization for inspection. Otherwise, a document with information related to the imported products must be completed.

What Are NO FARMIN Products?

Products not intended for pharmaceutical use are those not listed in the provisions of the BOE Law 14/1986, April 25, General Health Law, which details all the information regarding the importation of products regulated by the Spanish Agency for Medicines and Health Products (AEMPS).

Products considered intended for the pharmaceutical or cosmetic industry must undergo health control. The customs agent must request the required documents from the importer to introduce them into our borders.

The main products subject to inspection are the following:

  • Ginseng roots, coca leaves, poppy straw, tonka beans
  • Gums and resins
  • Juices and extracts
  • Sugars, lactose, maltose, glucose, and fructose
  • Petroleum oils, crude, vaseline, and mineral waxes
  • Hydrogen, noble gases, oxygen, and nitrogen oxide
  • Hydrocarbons, fluorides, hexachlorobenzene, and sulfates
  • Glands, gland extracts, human blood, serums, antiserums, vaccines, and medicines
  • Synthetic organic coloring matters and acid dyes
  • Perfumes, toilet waters, shaving liquids, and cosmetic products
  • Soaps, surfactants, and medicinal toiletries
  • Peptones and enzymes
  • Flat plates and films and X-ray products
  • Insecticides, rat poisons, fungicides, and herbicides
  • Hygiene or pharmacy articles such as vulcanized rubber, pharmacy clothing, gloves, mittens, and mitts
  • Pharmaceutical tissues, baby diapers, and hygiene articles

To know in detail which items are considered for pharmaceutical use, it is advisable to consult the complete list in the BOE.

The goods mentioned above may require various controls. They should always be accompanied by the following documentation:

  • Official pharmaceutical inspection document
  • Description of the item
  • Complete product code
  • Description of the goods
  • Number and type of packages
  • Container reference
  • Importer identification
  • Inspector’s approval

Additionally, for the importation of active ingredients, it must be demonstrated that the country of origin meets the GMP (Good Manufacturing Practices) requirements equivalent to those of the EU and is included in the list published by the European Commission.

The customs agent and the freight forwarder usually provide the importer with a list of the required documentation. However, it is advisable to prepare all these procedures in advance to save time on receiving the shipment. And, as we always recommend to our clients, selecting a trustworthy supplier is vital, as it will avoid many problems.

At Bull Importer, we manage the importation of pharmaceutical, cosmetic, and personal hygiene products daily. Our priority is to advise our clients so that their imports are carried out safely, efficiently, and without unforeseen events.

If you wish, we can take care of all the procedures and paperwork for importing your goods. Consult with us and discover all we can do for your business.

What Do You Get with Us Besides Peace of Mind and Security?

    1. We check that the product certificates comply with current CE regulations and not China Export.
    2. We verify that the supplier or manufacturer is legal, exists, and is solvent.
    3. You benefit from years of negotiations with freight forwarders, banks, carriers, customs agents, insurers, and the negotiated costs by volume of operations carried out over 25 years of management.
    4. You benefit from knowing that you are surrounded by the best specialists and technicians in the entire chain, from purchase to delivery of the product to your facilities.
    5. You ensure that a rigorous control and procedure will be followed, patented in intellectual property by the company’s CEO since 1986 and updated year by year as regulations, tariffs, dumping, anti-dumping, etc., have changed.
    6. You make all payments to Bull Importer and not to a company in China, India, Turkey, Bangladesh, or other countries, further guaranteeing the entire process.
    7. You save yourself from having to constantly and formally attend to all the repetitive documentation and justification to all the participants and authorities.
    8. You save yourself from having to pay attention for five years following the importation to possible inspections of your imports, caused by a lack of documentation or transparency or by unintentional non-compliance on your part caused by third parties (agents and freight forwarders) who did not do their job correctly.
    9. You save hours and hours of consultations, online courses, and advice for proper importation and accounting of the import.
    10. You get total prices, with all taxes and tariffs included up to your company, KNOWING IN ADVANCE the REAL PROFITABILITY OF YOUR IMPORT.
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