Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER THIRTEEN
Import and export
Section 72
Import authorisation
(1) Any person who wishes to import:
1. medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1,
2. active substances, which are of human, animal or microbial origin or are manufactured using genetic engineering, or
3. other substances of human origin intended for the manufacture of medicinal products on a commercial or professional basis, into the purview of this Act, from countries that are not Member States of the European Communities or other States Parties to the Agreement on the European Economic Area shall require a permit from the competent authority. Section 13 sub-section 4 and Sections 14 to 20a shall apply mutatis mutandis.
(2) Sub-section 1 shall apply to persons or facilities wishing to import medicinal products of human origin for direct use in human beings, on a commercial or professional basis, with the proviso that the authorisation may only be refused if the applicant fails to show evidence that qualified personnel and suitable premises are available for the assessment of the quality and safety of the medicinal products and for the conversion of the medicinal product into its usable form, should this prove necessary, according to the latest standards prevailing in science and technology.
(3) Sub-sections 1 and 2 shall not apply to:
1. tissues within the meaning of Section 1a number 4 of the Transplantation Act (Transplantationsgesetz),
2. autologous blood for the manufacturer of biotechnologically processed tissue products
3. tissue preparations within the meaning of Section 20c and
4. active substances intended for the manufacture of medicinal products according to a procedure described in the homeopathic section of the Pharmacopoeia.
(4) By way of derogation from sub-section 1, haematopoietic stem cells or stem cell preparations derived from peripheral blood or umbilical cord blood may only be imported by an importing establishment pursuant to Section 72b sub-section 1 sentence 1, from states that are neither Member States of the European Union nor other States Parties to the Agreement on the European Economic Area. The importing establishment shall require a permit from the competent authority. The decision on whether to grant the permit shall be taken by the competent authority of the Land in which the factory premises of the importing establishment are located or are to be located, in consultation with the competent higher federal authority. Sub-section 2 shall apply mutatis mutandis to the import for direct use.
(5) The application for a permit pursuant to sub-section 4 sentence 2 shall be accompanied by the information and documents specified in Annexes I and III part A of Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93 of 9.4.2015, p. 56) in the latest applicable version. By way of derogation from sentence 1, an application for a permit to import haematopoietic stem cells or stem cell preparations derived from peripheral blood or from umbilical cord blood for direct use in human beings, must be accompanied only by the information and documents specified in Annex I Parts A, B and C numbers 1 to 3 and in Annex III Part A numbers 1 and 3 of Commission Directive (EU) 2015/566. Sections 14 to 19 and Section 72b sub-sections 2c and 2d shall apply mutatis mutandis.
Section 72a
Certificates
(1) The importer may only import medicinal products within the meaning of Section 2 sub-sections 1 and 2 numbers 1, 1a, 2 and 4, or active substances, if:
1. the competent authority of the manufacturing country has confirmed by certificate that the medicinal products or active substances are manufactured in compliance with the requirements of recognized Good Practices in the Manufacture and Quality Control of Medicinal Products of the European Union, or equivalent standards, that the manufacturing facilities are regularly monitored, that appropriate measures including repeated and unannounced inspections are used for monitoring and, in the event of essential deviations from recognised principles, that the competent authority is informed and that such certificates as refer to medicinal products within the meaning of Section 2 sub-sections 1 and 2 number 1, which are intended for administration to human beings, and active substances that are of human, animal or microbial origin, or are active substances manufactured using genetic engineering are mutually recognised,
2. the competent authority has attested that the afore-mentioned requirements have been adhered to in manufacturing and assuring the quality of the medicinal products and the active substances used in their manufacture in so far as they are of human or animal origin or are manufactured using genetic engineering, or in the manufacture of the active substances, or
3. the competent authority has attested that the import is in the interests of the general public.
In the case of haematopoietic stem cells, or stem cell preparations derived from peripheral blood or from umbilical cord blood with the exception of those intended for direct use in human beings and those intended for targeted administration to a specific person, the importing establishment shall keep the documents specified in Annex III part B of Commission Directive (EU) 2015/566 available and present them to the competent authorities upon request. The competent authority may only issue an attestation pursuant to:
1. sentence 1 number 2, if no certificate pursuant to sentence 1 number 1 exists and it or a competent authority of a Member State of the European Union or of another State Party to the Agreement on the European Economic Area has satisfied itself regularly in the country of manufacture that the above-mentioned requirements are being observed in manufacturing the medicinal products or the active substances,
2. sentence 1 number 3, if no certificate pursuant to sentence 1 number 1 exists and an attestation pursuant to sentence 1 number 2 is not envisaged or not possible.
(1a) Sub-section 1 sentence 1 shall not apply to:
1. medicinal products intended for a clinical trial on human subjects, or for use in the context of a compassionate use programme,
2. medicinal products of human origin for direct use or haematopoietic stem cell preparations made from peripheral blood or umbilical cord blood intended for targeted administration to a specific person,
3. active substances that are of human, animal or microbial origin and are intended for the manufacture of a medicinal product according to a procedure described in the homeopathic section of the Pharmacopoeia,
4. active substances which are or contain substances pursuant to Section 3 numbers 1 to 3, in so far as they are not subject to the requirements of Good Manufacturing Practice in keeping with the principles and guidelines of the European Commission,
5. tissues within the meaning of Section 1a number 4 of the Transplantation Act (Transplantationsgesetz),
6. autologous blood for the manufacture of biotechnologically processed tissue products
7. tissue preparations within the meaning of Section 20c and
8. active substances that are manufactured in and imported from a state that is not a member of the European Union or another State Party to the Agreement on the European Economic Area and that is specified in the list published by the European Commission pursuant to Article 11 (1b) of Directive 2001/83/EC.
(1b) The provisions laid down in sub-section 1 sentence 1 numbers 1 and 2 for active substances of human, animal or microbial origin or for active substances manufactured using genetic engineering shall apply mutatis mutandis to other substances of human origin intended for the manufacture of medicinal products.
(1c) Medicinal products and active substances of human, animal or microbial origin or active substances manufactured using genetic engineering as well as other substances of human origin intended for the manufacture of medicinal products with the exception of those medicinal products specified in sub-section 1a numbers 1 and 2, may not be imported on the basis of a certificate pursuant to sub-section 1 sentence 1 number 3.
(1d) Sub-section 1 sentence 1 shall be applicable to the import of active substances as well as other substances of human origin intended for the manufacture of medicinal products, in so far their supervision is regulated by an ordinance pursuant to Section 54.
(1e) The competent authority shall issue the holder of the permit pursuant to Section 72 sub-section 4 sentence 2 with an attestation pursuant to the provisions of Annex II of Directive (EU) 2015/566, if a certificate pursuant to sub-section 1 sentence 1 number 1 has been issued, or the prerequisites are fulfilled for a certificate pursuant to sub-section 1 sentence 1 number 2 in conjunction with sub-section 1 sentence 3 number 1.
(2) The Federal Ministry is hereby empowered to mandate, by ordinance subject to the approval of the Bundesrat, that substances and preparations from substances which can be used as medicinal products or in the manufacture of medicinal products may not be imported, in so far as this is necessary to prevent hazards to human health or for the purpose of taking precautions against risks.
(3) The Federal Ministry is hereby also empowered to specify, by means of ordinance with the approval of the Bundesrat, the additional requirements for the import of the medicinal products specified under sub-section 1a numbers 1 and 2 from countries that are not Member States of the European Union or other States Parties to the Agreement on the European Economic Area, in so far as necessary to ensure that the medicinal products are of proper quality. In this context, the Ministry can lay down regulations, in particular, which govern the tests to be carried out by the competent person pursuant to Section 14 and the possibility of supervision by the competent authority of the manufacturing country.
Section 72b
Import authorisations and certificates for tissues and specific tissue preparations
(1) Tissues within the meaning of Section 1a number 4 of the Transplantation Act or tissue preparations within the meaning of Section 20c sub-section 1 sentence 1 or sentence 2 may only be imported by an importing tissue establishment that conducts this activity commercially or professionally and has signed a contract on the importation, with a third country supplier. A third country supplier is a tissue establishment or other agency of a state that is neither a Member State of the European Union nor another State Party to the Agreement on the European Economic Area, which is responsible for the export of tissues or tissue preparations that it delivers to the importing tissue establishment. The importing tissue establishment shall require an authorisation from the competent authority. The decision on whether to grant the authorisation shall be taken by the competent authority of the Land in which the factory premises of the importing tissue establishment are located or are to be located, in consultation with the competent higher federal authority. Section 72 sub-section 2 shall apply mutatis mutandis to the import of tissue preparations for direct use.
(1a) The application for authorisation pursuant to sub-section 1 sentence 3 shall be accompanied by the information and documents specified in Annexes I and III part A of Commission Directive (EU) 2015/566. By way of derogation from sentence 1, an application for authorisation to import tissue preparations for direct use in human beings, must be accompanied only by the information and documents specified in Annex I parts A, B and C numbers 1 to 3 of Commission Directive (EU) 2015/566. Section 20c sub-sections 2 to 5 and 7 shall apply mutatis mutandis.
(2) The importing tissue establishment pursuant to sub-section 1 may only import tissues or tissue preparations into the territory governed by this Act if:
1. the authorities of the country of origin have confirmed in a certificate that the removal, laboratory tests, processing, preservation, storage or testing were conducted according to standards which are at least equivalent to the Standards of Good Practice laid down by the European Union, and such certificates are mutually recognised, or
2. the authority responsible for the importing tissue establishment certifies that the standards of Good Practice for the procurement, laboratory tests, processing, preservation, storage or testing of tissues are being observed after that authority or a competent authority of another Member State of the European Union, or a State Party to the Agreement on the European Economic Area has satisfied itself thereof, in the manufacturing country, or
3. the authority responsible for the importing tissue establishment has certified that importing is in the public interest, if a certificate pursuant to number 1 is not available and an attestation pursuant to number 2 is not possible.
The importing tissue establishment shall keep the documents specified in Annex III part B of Commission Directive (EU) 2015/566 available and present them to the competent authorities upon request. By way of derogation from sentence 1 number 2, the competent authority can dispense with an inspection of the removal facility in the country of origin, if the documents submitted by the importing tissue establishment give no reason for complaint or if his/her facilities or factory sites, as well as the quality assurance system of the party procuring the tissue in the country of origin, is already known to them.
(2a) The competent authority shall issue the holder of an authorisation pursuant to sub-section 1 with a certificate pursuant to Annex II of Directive (EU) 2015/566, if a certificate pursuant to sub-section 2 sentence 1 number 1 has been issued, or the prerequisites are fulfilled for an attestation pursuant to sub-section 2 sentence 1 number 2 also in conjunction with sub-section 2 sentence 3.
(2b) Sub-sections 2 and 2a shall not apply to haematopoietic stem cell preparations from bone marrow that are intended for targeted administration to a specific person.
(2c) The holder of an authorisation pursuant to sub-section 1 sentence 3 shall make prior notification of any modification to the prerequisites specified in Section 20c sub-section 2, and of any material change in its importing activities, to the competent authority and shall submit evidence thereof. The holder of the authorisation may only conduct the change when the competent authority has authorised it in writing. In particular, changes referring to the following shall be considered to be essential changes in the importing activity:
1. the type of tissue or tissue preparation imported,
2. activities conducted in a third country that is neither a Member State of the European Union nor another State Party to the Agreement on the European Economic Area, which can have an effect on the quality and safety of the imported tissues and tissue preparations, or
3. the third country suppliers used.
If the holder of the authorisation undertakes a one-off import, within the meaning of Section 72c sub-section 2, of tissues or tissue preparations from a third country supplier that does not fall under that authorisation, such a one-off import shall not be considered an essential change, in so far as the authorisation of the importing tissue establishment covers the importation of the same type of tissue or tissue preparation from another third country supplier.
(2d) The holder of the authorisation shall notify the competent authority immediately of the following:
1. the revocation, the withdrawal or the order to suspend the authorisation, permit, attestation of a third-country supplier of tissues or tissue preparations by the competent authority of the State in which the third-country supplier is domiciled,
2. every other decision that:
a) was taken because of non-compliance with provisions of the competent authority of the State in which the third-country supplier is domiciled, and
b) can be relevant for the quality and safety of the imported tissues and tissue preparations,
3. the complete or partial discontinuance of its import activity and
4. an unforeseen change in the responsible person pursuant to Section 20c.
(3) The Federal Ministry is hereby empowered to stipulate the additional requirements for the import of tissues or tissue preparations pursuant to sub-section 2, by ordinance subject to the approval of the Bundesrat, so as to guarantee that tissues and tissue preparations are of proper quality. It can lay down, in particular, regulations concerning the tests to be conducted by the responsible person pursuant to Section 20c and the conduct of surveillance in the country of origin by the competent authority.
(4) Sub-section 2 sentence 1 shall apply to the import of tissues and tissue preparations within the meaning of sub-section 1, in so far as its surveillance is regulated by an ordinance pursuant to Section 54, Section 12 of the Transfusion Act or pursuant to Section 16a of the Transplantation Act.
(5) (repealed)
Section 72c
One-off import of tissues and tissue preparations
(1) Tissues within the meaning of Section 1a number 4 of the Transplantation Act or tissue preparations within the meaning of Section 20c, sub-section 1 sentence 1 or sentence 2 that are the object of a one-off import, may only be imported by an importing tissue establishment within the meaning of Section 72b sub-section 1 sentence 1. The importing tissue establishment shall require an authorisation for the one-off import from the competent authority. The decision on whether to grant the authorisation shall be taken by the competent authority of the Land in which the factory premises of the importing tissue establishment are located or are to be located, in consultation with the competent higher federal authority.
(2) A one-off import is the import of any tissue or tissue preparation on behalf of a specific person who has stored this tissue or tissue preparation with a third-country supplier for future personal use or for that of first-degree or second-degree relatives. It is permitted to dispense the tissue or the tissue preparation to a person who is a physician and who is intended to administer the tissue or tissue preparation to the specific person or his/her close relative. The dispensing of the tissue or tissue preparation to persons other than the above-mentioned persons is prohibited.
(3) The application for authorisation pursuant to sub-section 1 sentence 2 shall be accompanied by the information and documents specified in Annex I with the exception of part F of Commission Directive (EU) 2015/566. Section 20c sub-sections 2 to 5 and 7 shall apply mutatis mutandis. The competent authority shall issue the holder of an authorisation pursuant to sub-section 1 sentence 2 with a certificate pursuant to Annex II of Directive (EU) 2015/566. Section 72b sub-section 2c sentences 1 and 2 and sub-section 2d shall apply mutatis mutandis.
(4) Sub-sections 1 to 3 shall apply mutatis mutandis to haematopoietic stem cells and stem cell preparations derived from peripheral blood or from umbilical cord blood. By way of derogation from sub-section 3 sentence 2, the requirements contained in Sections 14 to 19 shall be applied mutatis mutandis.
Section 73
Prohibition of introduction
(1) Medicinal products that are subject to compulsory marketing authorisation, to authorisation pursuant to Section 21a or registration may only be introduced into the purview of this Act, if they are authorised, authorised pursuant to Section 21a, or registered for placing on the market within the purview of this Act or if they have been exempted from the obligation to obtain the marketing authorisation or registration and if:
1. in the case of introduction from a Member State of the European Union or another State Party to the Agreement on the European Economic Area, the recipient is a pharmaceutical entrepreneur, a wholesaler or veterinarian or runs a pharmacy or, as a hospital operator pursuant to the Pharmacy Act, is supplied by a pharmacy from a Member State of the European Union or of another State Party to the Agreement on the European Economic Area,
1a. in the case of shipment to the final consumer, the medicinal product is shipped, according to the German regulations governing sale at a distance or electronic commerce, by a pharmacy of a Member State of the European Union or another State Party to the Agreement on the European Economic Area, which is authorised to conduct sale at a distance under its national laws, in so far as they correspond to German pharmacy law as regards the provisions governing sale at a distance, or according to the German Act on Pharmaceutical Services, or
2. in the case of introduction from a country which is not a Member State of the European Union or another State Party to the Agreement on the European Economic Area, the recipient is the holder of an authorisation pursuant to Section 72, Section 72b or Section 72c.
The medicinal products specified in Section 47a sub-section 1 sentence 1 shall only be introduced into the purview of this Act if the recipient is one of the facilities mentioned there. The Federal Ministry shall publish at regular intervals an updated overview of the Member States of the European Union and the other States Parties to the Agreement on the European Economic Area, in which safety standards exist with respect to sale at a distance and electronic commerce in medicinal products which are comparable with those laid down in German law.
(1a) Medicated feeding stuffs may only be introduced into the purview of this Act if:
1. they comply with the medicinal product-related provisions in force within the purview of this Act, and
2. the recipient belongs to the group of persons specified in sub-section 1, or is an animal keeper in the case of Section 56 sub-section 1 sentence 1.
(1b) It is prohibited to introduce counterfeit medicinal products or counterfeit active substances into the territorial scope of this Act. The competent authority can, in justified cases, make exceptions for the purposes of testing or criminal prosecution.
(2) Sub-section 1 sentence 1 shall not apply to medicinal products that:
1. are intended, in individual cases and in small amounts, for supplying particular animals with medicinal products at animal shows, tournaments or similar events,
2. are intended for scientific and research establishments’ own requirements and needed for scientific purposes with the exception of medicinal products intended for use in clinical trials on human beings,
2a. are needed in small quantities by a pharmaceutical entrepreneur, an enterprise with an authorisation pursuant to Section 13 or a testing laboratory as samples for inspection or for analysis purposes,
2b. are introduced from a Member State of the European Union or another State Party to the Agreement on the European Economic Area by an enterprise authorised pursuant to Section 13, either for the purpose of treating or processing and the subsequent shipping onwards or shipping back or for the purpose of manufacturing a medicinal product authorised for placing on the market on the territory governed by this Act,
3. are conveyed under customs supervision through the territory governed by this Act or are transferred to a bonded warehouse procedure or a free zone of control type II or to a free zone of control type I or to a bonded warehouse,
3a. are authorised in a Member State of the European Union or another State Party to the Agreement on the European Economic Area and even after transit storage with a pharmaceutical entrepreneur, manufacturer or wholesaler, are to be re-exported, shipped onwards or shipped back,
4. are introduced for the head of state of a foreign country or for his/her escort and are intended for use during his/her stay within the purview of this Act,
5. are intended for the personal use or consumption of members of diplomatic missions or consular representations within the purview of this Act or of officials of international organizations located there or of their family members, in so far as these persons are neither German nor have their permanent residence within the purview of this Act,
6. are introduced when entering into the purview of this Act in an amount corresponding to the normal personal requirement, or corresponding to the normal requirement of the accompanying non-food producing animals,
6a. may be placed on the market in the country of origin and are purchased, without a commercial or professional intermediary, in a quantity that corresponds to the amount needed for normal personal use in a Member State of the European Union or another State Party to the Agreement on the European Economic Area,
7. are carried on board any means of transport and are intended exclusively for the use of or consumption by persons conveyed by these means of transport,
8. are intended for use or consumption on sea-going vessels and are consumed on board ships,
9. are sent as samples to the competent higher federal authority for the purpose of obtaining a marketing authorisation or for official batch testing,
9a. are needed by the competent higher federal authority as samples for analytical purposes within the framework of pharmacovigilance,
10. are procured by federal or Land authorities in interstate commerce.
(3) By way of derogation from sub-section 1 sentence 1, finished medicinal products that are intended for use in human beings and are not authorised for marketing or registered for trade within the purview of this Act or that are not exempted from the obligation to obtain a marketing authorisation or registration, may be introduced into the purview of this Act:
1. if they are ordered by pharmacies on the basis of an order received from individual persons in a small quantity and are dispensed by these pharmacies within the framework of the existing pharmacy operating licence,
2. if they may be legally placed on the market in the State from which they are introduced into the territorial scope of this Act, and
3. if no medicinal product for the therapeutic indication in question, which is identical in terms of the active substance and comparable in terms of the strength, is available within the purview of the Act, or if they are ordered in the appropriate quantity needed to ensure the proper treatment of the hospital’s patients, for the purpose of temporarily stocking a hospital pharmacy or a hospital supply pharmacy, under the prerequisites contained in number 2, and dispensed by this hospital pharmacy or hospital supply pharmacy under the prerequisites contained in number 3 within the framework of the existing pharmacy operating licence, for the purpose of administration to a patient of said hospital, under the direct personal responsibility of a physician, or if they are to be held in stock for emergencies pursuant to the provisions of the legislation on pharmacies or the requirements of occupational accident insurance, or within the sphere of responsibility of the Federal Ministry of Defence, or must be procured at short notice, if medicinal products for the therapeutic indication are not available. Ordering pursuant to sentence 1 number 1 and dispensing pursuant to sentence 1 of medicinal products introduced into the territory governed by this Act from Member States of the European Union or other States Parties to the Agreement on the European Economic Area require a prescription from a physician or dentist. Further details shall be settled by the Pharmacies’ Operation Regulations.
(3a) By way of derogation from sub-section 1 sentence 1, tissue preparations that are not approved pursuant to Section 21a sub-section 1 for placing on the market within the purview of this Act and haematopoietic stem cell preparations made from peripheral blood or umbilical cord blood that are not authorised pursuant to Section 21 for placing on the market within the purview of this Act, nor approved pursuant to Section 21a sub-section 1 for import into the territory governed by the present Act if:
1. they are ordered, in small quantities, by a facility that is the holder of an authorisation pursuant to Sections 13, 20c, 52a, 72, 72b, or pursuant to Section 72c to conduct activities with these tissue preparations or haematopoietic stem cell preparations from peripheral blood or from umbilical cord blood, based on an existing order placed by an individual, and dispensed by this establishment to the administrating hospital or the administrating position,
2. they may be legally placed on the market in the state from which they are imported into the purview of this Act,
3. for the therapeutic indication in question, no medicinal product that is comparable in terms of functionality is available within the purview of this Act, and
4. in the event that the medicinal product is imported from a country that is not a Member State of the European Union or a State Party to the Agreement on the European Economic Area, ordering and dispensing is based on a medical prescription.
(3b) By way of derogation from sub-section 1 sentence 1, finished medicinal products that are not registered or authorised for trade within the purview of this Act, or are exempted from the authorisation or registration for the purpose of use in animals, may be introduced into the purview of this Act if:
1. they are ordered by pharmacies for veterinarians or animal keepers and are dispensed by these pharmacies within the framework of the existing pharmacy operating licence or are ordered by a veterinarian operating a veterinary in-house dispensary for the animals he/she treats,
2. they are authorised for use in animals in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area, and
3. within the purview of this Act, no other authorised medicinal product intended for administration to animals is available to achieve the treatment objective.
The ordering and dispensing by pharmacies may only be done on the basis of a veterinary prescription. Sub-section 3 sentence 3 shall apply mutatis mutandis. Veterinarians who order medicinal products pursuant to sentence 1, obtain them from pharmacies or prescribe them shall notify the competent authority immediately thereof. The notification must state the species and therapeutic indication for which the medicinal product is intended, the State from which the medicinal product is brought into the purview of this Act, the name and quantity of the medicinal product ordered as well as its active substances by type and quantity.
(4) The provisions of this Act shall not be applicable to medicinal products pursuant to sub-section 2 numbers 4 and 5. The provisions of this Act shall not be applicable to medicinal products pursuant to sub-section 2 numbers 1 to 3 and 6 to 10 and sub-sections 3 and 3a, with the exception of Sections 5, 8, 13 to 20a, 52a, 64 to 69a and 78, and furthermore in the cases referred to in sub-section 2 number 2 and sub-sections 3 and 3a, also with the exception of Sections 48, 95 sub-section 1 numbers 1 and 3a, sub-sections 2 to 4, Section 96 numbers 3, 10 and 11 and Section 97 sub-sections 1, 2 numbers 1 and 9 as well as sub-section 3, and furthermore in the cases referred to in sub-section 3a and also with the exception of Sections 20b to 20d, 72, 72b, 72c, 96 number 18b and 18d and of Section 97 sub-section 2 number 7a. The provisions of this Act shall not apply to medicinal products pursuant to sub-section 3b, with the exception of Sections 5, 8, 48, 52a, 56a, 57, 58 sub-section 1 sentence 1, Sections 59, 64 to 69a, 78, 95 sub-section 1 numbers 1, 3a, 6, 8, 9 and 10, sub-sections 2 to 4, Section 96 numbers 3, 13, 14 and 15 to 17, Section 97 sub-sections 1 and 2 numbers 1 and 21 to 24 and 31 and sub-section 3, as well as the provisions contained in the Ordinance on Veterinary In-House Dispensaries issued on the basis of Section 12 sub-section 1 numbers 1 and 2 and sub-section 2, Section 48 sub-section 2 number 4 and sub-section 4, Section 54 sub-sections 1, 2 and 3, as well as Section 56a sub-section 3 and in the ordinance on the obligation to produce supporting documents for medicinal products intended for use on animals issued on the basis of Sections 12, 54 and 57.
(5) When exercising their profession in the context of local border traffic within the meaning of Regulation (EC) No. 1931/2006 of the European Parliament and of the Council of 20 December 2006 laying down rules on local border traffic at the external land borders of the Member States and amending the provisions of the Schengen Convention (OJ L 405 of 30.12.2006, p. 1), physicians and veterinarians may only carry medicinal products with them which have been authorised for marketing or registered within the purview of this Act or which are exempted from the obligation to obtain a marketing authorisation or registration. By way of derogation from sub-section 1 sentence 1, physicians who provide health care services within the meaning of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border health care (OJ L 88 of 04.04.2011, p. 45) may carry with them small amounts of medicinal products authorised in the place where they are established, in the original packaging, in the quantity that is necessary for providing their cross-border health care services, if and in so far as medicinal products with the same composition and intended for the same therapeutic indications are also authorised for marketing within the purview of this Act; the physician may only administer these medicinal products himself/herself. Furthermore, by way of derogation from sub-section 1, sentence 1 veterinarians who render services as nationals of a Member State of the European Union or of another State Party to the Agreement on the European Economic Area within the meaning of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376 of 27.12.2006, p. 36), may carry with them small amounts of medicinal products which are authorised for marketing in the place where they are established, in a quantity which is necessary for the performance of the services, and in the original packaging, if and in so far as medicinal products with the same composition and intended for the same therapeutic indications are also authorised for marketing within the purview of this Act; the veterinarian may only administer these medicinal products himself. He/she shall inform the animal keeper of the withdrawal period specified for the corresponding medicinal product authorised for marketing within the purview of this Act.
(6) In the case of sub-section 1 sentence 1 number 2, as well as sub-section 1a number 2, in conjunction with sub-section 1 sentence 1 number 2, the presentation of a certificate issued by the authorities competent in the recipient’s case, containing information on the type and quantity of the medicinal product and confirming that the requirements specified in sub-section 1 or sub-section 1a have been met, shall be necessary for customs clearance for free circulation. The customs office shall forward the certificate to the authorities which issued it, at the expense of the party paying the customs duties.
(7) In the case of sub-section 1 number 1, a recipient who is a wholesaler or who runs a pharmacy shall prove the existence of the provision for coverage pursuant to Section 94.
Section 73a
Export
(1) By way of derogation from Sections 5 and 8 sub-sections 1 and 2, the medicinal products referred to there may be exported or removed from the purview of this Act if the competent authority of the country of destination has authorised the import or introduction of such medicinal products. The authorisation pursuant to sentence 1 must state that the competent authority of the country of destination is cognisant of the grounds for refusal which prevent the marketing of said medicinal products within the purview of this Act.
(2) The competent authority or the competent higher federal authority, in so far as authorisation-related information is concerned and the authorisation holder has his/her place of business outside of the purview of this Act, shall issue a certificate corresponding to the World Health Organization’s Certification Scheme at the request of the pharmaceutical entrepreneur, the manufacturer, the exporter or the competent authority of the country of destination. If the request is submitted by the competent authority of the country of destination, the consent of the manufacturer is to be obtained prior to issuing the certificate.
Section 74
Participation of customs offices
(1) The Federal Ministry of Finance and the customs offices specified by it shall participate in the supervision of the introduction of medicinal products and active substances into the purview of this Act and of the export of the same. The authorities named may:
1. retain for inspection consignments of the type named in sentence 1, as well as their means of conveyance, containers, loading and packing material,
2. notify the competent administrative authorities of suspected violations of prohibitions and restrictions of this Act or of the ordinances issued pursuant to this Act, if this suspicion becomes evident during the execution of their duties,
3. issue instructions to the effect that, in instances defined in number 2, consignments of the type named in sentence 1 shall be presented to a competent medicinal product supervision authority at the cost and at the risk of the person holding the right of disposal of the consignment.
The inviolability of the secrecy of mail pursuant to Article 10 of the Basic Law shall be restricted in compliance with sentences 1 and 2.
(2) The Federal Ministry for Finance shall settle the details of the procedure indicated in sub-section 1, in agreement with the Federal Ministry, by ordinance not subject to the approval of the Bundesrat. In particular, it may thereby envisage obligations to notify, register, submit information and provide assistance, as well as to tolerate the inspection of business papers and other documents and of premises and the taking of samples free of charge. The ordinance shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, as far as radiopharmaceuticals and active substances or medicinal products and active substances in the manufacture of which ionizing radiation is used are concerned and in agreement with the Federal Ministry of Food and Agriculture where medicinal products intended for administration to animals are involved.
Leave a Reply