Basic materials for medical devices; application for a declaration of safety

If you need a certificate for presentation to customs or an authority in a third country for the import of basic substances or mixtures containing basic substances or natural products, you can apply for a declaration of no objection.

Description

Declarations of no objection can be important for you so that your supplier in the third country is granted an export license by its authority for the basic substance or mixture or natural product, if this substance is contained.
Basic substances are also formally referred to as scheduled substances, and are suitable for producing narcotics. Mixtures of substances or natural products fall under precursors if they themselves can be easily used or the precursor they contain can be easily and economically recovered from them.
You can apply for a declaration of no objection for:

  • the import of the following substances into the European Union:
    • Category 2
      • Red phosphorus
      • Acetic anhydride
      • Phenylacetic acid
      • Anthranilic acid
      • Piperidine
      • potassium permanganate and
      • the salts of the listed substances, if the presence of such salts is possible
      • or mixtures of substances containing these substances, if they can be easily and economically recovered therefrom
    • Category 3
      • Hydrochloric acid
      • sulfuric acid
      • toluene
      • ethyl ether
      • acetone
      • methyl ethyl ketone and
      • the salts of the listed substances, provided the presence of such salts is possible and they are not salts of hydrochloric acid and sulfuric acid
      • or mixtures of substances containing these substances, if they can be easily and economically recovered therefrom
  • Drop shipments of the following precursors:
    • Category 1
      • 1-phenyl-2-propanone
      • Methyl alpha-acetylphenyl acetate (MAPA)
      • Methyl 2-methyl-3-phenyl-2-oxiranecarboxylate (BMK methyl glycidate)
      • 2-methyl-3-phenyl-2-oxiranecarboxylic acid (BMK glycidic acid)
      • N-acetylanthranilic acid
      • Alpha-phenylacetoacetamide (APAA)
      • Alpha-phenylacetoacetonitrile (APAAN)
      • Isosafrole (cis + trans)
      • 3,4-methylenedioxyphenyl-propan-2-one
      • Piperonal
      • Safrole
      • Methyl 3-(1,3-benzodioxol-5-yl)-2-methyl-2-oxiranecarboxylate (PMK methyl glycidate)
      • 3-(1,3-benzodioxol-5-yl)-2-methyl-2-oxiranecarboxylic acid (PMK glycidic acid)
      • 4-Anilino-N-phenethylpiperidine (ANPP)
      • N-phenethyl-4-piperidone (NPP)
      • Ephedrine
      • Pseudoephedrine
      • Norephedrine
      • Ergometrine
      • Ergotamine
      • Lysergic acid
      • (1R,2S)-(-)-chloroephedrine
      • (1S,2R)-(+)-chlorophedrine
      • (1S,2S)-(+)-chloropseudoephedrine
      • (1R,2R)-(-)-chloropseudoephedrine
      • the stereoisomers of the listed substances, with the exception of cathine, insofar as the existence of such forms is possible.
      • the salts of the listed substances, insofar as the existence of such salts is possible and they are not salts of cathine.
    • substances of the above mentioned categories 2 and 3
    • or mixtures of substances containing these substances, if they can be easily and economically recovered from them.
  • the import of mixtures of substances or natural products containing a basic substance of category 1, if it cannot be easily and economically recovered therefrom.

More detailed information on the substances can be found in the relevant legal bases.
For the handling of these substances or mixtures or natural products, if these substances are contained, the following are required, if applicable

  • a permit or registration and
  • if exported to third countries, an export license is required.

Prerequisites

  • You must be a resident of Germany.
  • When applying for a declaration of clearance for drop shipments of category 1 precursors, you must be in possession of a permit.
  • When applying for a declaration of clearance for a category 2 precursor, you must be in possession of a registration.

Procedure

You can apply for the declaration of safety informally by e-mail or by mail. The BfArM will review your application. If further information is required, the BfArM will contact you. If you are granted the declaration of safety, the BfArM will send it to you by your preferred method.

Deadlines

The declarations of clearance are usually valid for between 6 and 12 months. In the case of a drop shipment, the period of validity of the declaration of clearance depends on any import permit issued by the consignee.

Processing time

usually 2 to 3 weeks

Required documents

  • Required Documents

    Für Mischungen oder Naturprodukte:

    • Analysenzertifikat oder Sicherheitsdatenblatt oder beides
    • bei Streckengeschäften mit Grundstoffen der Kategorie 1: Kopie der Einfuhrgenehmigung des Empfängers im Drittland

Fees

  • There are no fees for you.

Legal bases

Remedy

  • Appeal.
    Detailed information on how to appeal can be found in the decision on your application.

Links to more information

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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