Guidelines on parallel import
The Danish Medicines Agency has issued its Guidelines on parallel import of medicinal products, no. 9107 of 27 February 2018.
The guidelines replace Guidelines on parallel import of medicinal products, no. 9181 of 29 January 2014.
No. 9107 of 27 February 2018
Ministry of Health
(Danish Medicines Agency)
Scope of and conditions for parallel import
1.1 Definitions
1.2 Introduction
1.3 Conditions for parallel import
1.4 Parallel import from new member states (Specific mechanism)
1.5 Biological medicinal products
1.6 Scope of a marketing authorisation
1.7 Changes to a parallel imported medicinal product
1.8 Company authorisation
Application for parallel import marketing authorisation
2.1 Electronic applications
2.2 Fees
2.3 Documentation of company authorisation
2.4 Language
2.5 Name
2.6 Labelling and package leaflets
2.7 Shelf life
2.8 Case handling times
Related issues
3.1 Clinical trials
3.2 Free samples of medicinal products
3.3 Reporting of adverse reactions
3.4 Relationship with other legislation
3.5 Withdrawal of the previous guidelines
Section 1
Scope of and conditions for parallel import
1.1 Definitions
The term ‘parallel import’ implies that a medicinal product, for which the Danish Medicines Agency has already granted a marketing authorisation, is imported into Denmark through other distribution channels than the ones agreed with the patent holder. Foreign as well as Danish medicinal products may be imported in parallel. Likewise, medicinal products for both human and veterinary application may be imported in parallel. Certain minor deviations in a parallel imported product are acceptable on the condition that the therapeutic effect does not deviate from the original and directly distributed product.
The term ‘exporting country’ refers to the EU/EEA country from which a parallel imported medicinal product is to be imported and where the current marketing authorisation has been issued. However, it is not a requirement that the imported batch of the medicinal product has physically been in the country concerned, but it must in any case have been released in an EU/EEA country.1) The term ‘directly distributed medicinal product’ refers to a medicinal product traded in Denmark through a distribution channel agreed with the patent holder, and the parallel import takes place in relation to this medicinal product.
These guidelines do not deal with parallel distribution of medicinal products authorised by a European Community marketing authorisation under the rules in Regulation (EC) No. 726/2004. The guidance on parallel distribution is available at EMEA's website.
1.2 Introduction
The Danish Medicines Agency administers parallel import of medicinal products pursuant to the executive order on marketing authorisation for medicinal products and based on articles 34 and 36 of the EC Treaty and the Commission Communication of 30 December 2003 on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. Moreover, relevant EU judgments are observed, including the De Peijper judgment (see reference in appendix), on which the Commission Communication is based, the Paranova judgments as well as the Kohlpharma judgment (see reference in appendix).
The De Peijper judgment concludes that any legislation or practice restricting the import to take place exclusively through certain traders, precluding others, falls under the prohibition against restrictions on imports laid down in article 34 of the Treaty. This also applies to medicinal products, notwithstanding that legal marketing of a medicinal product is subject to the national authorities’ authorisation of the medicinal product in question. Therefore, parallel import of already authorised medicinal products is legal on certain conditions.
Moreover, the judgment concludes that legislation or practice enabling monopolisation of import cannot be justified of consideration for the protection of the health and life of humans or animals, cf. article 36 of the Treaty, if this purpose can be achieved with less restrictive measures. One consideration in this connection is that the national authorities are already in possession of the required documentation for the medicinal product via the first marketing authorisation and that, through a higher degree of cooperation between the EU/EEA member states, the countries will be able to obtain the information required.
Furthermore, the De Peijper judgment concludes that varieties of an already authorised medicinal product can also be imported in parallel as long as there are no differences of therapeutic significance between the products.
Thus, it cannot be made a condition for granting a marketing authorisation for parallel import of a medicinal product that the parallel importer submits full documentation, as the product is essentially identical with an already authorised medicinal product, and as the Danish Medicines Agency already holds the required documentation.
Under section 7 of the Danish Medicines Act, medicinal products must be authorised by a marketing authorisation issued by the Danish Medicines Agency before they may be sold or distributed. The requirement as to prior authorisation also applies to parallel imported medicinal products, which may therefore not be sold or distributed until the Danish Medicines Agency has issued a marketing authorisation for parallel import.
Authorisation for parallel import of a medicinal product can be applied for by filling in a special application form that can be downloaded from the Danish Medicines Agency's website.
The main objective of the Danish Medicines Agency’s consideration of an application for a parallel import authorisation is to establish whether the required identity exists between the medicinal product distributed directly and the medicinal product for which an application for parallel import has been submitted. The Danish Medicines Agency ensures that the medicinal product for which an application has been submitted meets the requirements for parallel import (see section 1.3) and bases its decision on whether the medicinal product for which the application has been submitted meets the requirements of the Danish Medicines Act – just as the directly distributed medicinal product does.
Furthermore, the Danish Medicines Agency assesses the parallel importer’s suggestions for repacking, labelling and package leaflet of the parallel imported medicinal product (see sections 2.5 and 2.6).
If the Danish Medicines Agency is not able to obtain all information about a parallel imported medicinal product, the application will be rejected if, upon a concrete evaluation of the case in question, the Danish Medicines Agency finds that there may be significant differences in the therapeutic effect of the parallel imported product and the directly distributed medicinal product.
1.3 Conditions for parallel import
The conditions relating to parallel import are laid down in section 35 of the Danish executive order on marketing authorisation for medicinal products as follows:
»Section 35. The following requirements must be met in order for the Danish Medicines Agency to issue a marketing authorisation for a parallel imported medicinal product:
1. The directly distributed medicinal product, in relation to which an application for parallel import of a medicinal product has been submitted, must hold a marketing authorisation that is valid in Denmark. Moreover, the two medicinal products must contain the same active substance and have the same pharmaceutical form,
2. the parallel imported medicinal product must be imported from an EU/EEA country,
3. the parallel imported medicinal product must be covered by an existing marketing authorisation from an EU/EEA country (hereinafter referred to as ‘the exporting country’), and
4. there must not be any differences of therapeutic significance between the parallel imported and the directly distributed medicinal product.
Subsection 2. Marketing authorisation applications for parallel imported medicinal products must be submitted using an application form drawn up by the Danish Medicines Agency.
Subsection 3. An application must be submitted for a marketing authorisation for parallel import from each individual exporting country.«
In its decision as to whether any differences are of therapeutic significance, the Danish Medicines Agency handles the case reviewed pursuant to the guidelines applicable to subsequent changes to authorised directly distributed medicinal products.
Thus, to obtain a parallel import authorisation, it is a condition that, at the time of application, a marketing authorisation exists for the directly distributed medicinal product in relation to which an application for parallel import is submitted. The directly distributed medicinal product must be authorised pursuant to section 8(1) of the Danish Medicines Act, and therefore a parallel imported medicinal product cannot be specified as a directly distributed medicinal product.
At the time of application, the parallel importer must specify the directly distributed medicinal product, relative to which parallel import is to take place. If any common origin or licensing agreement exists between the marketing authorisation holder of the parallel imported medicinal product in the exporting country and the marketing authorisation holder of the directly distributed medicinal product in Denmark, it is a significant factor that may help the Danish Medicines Agency to establish the required identity between the two products.
With its ruling in case C-112/02 “Kohlpharma”, the Court of Justice of the European Union rejected the member states’ condition that a common origin or a licensing agreement must exist between the marketing authorisation holder of the parallel imported medicinal product and the marketing authorisation holder of the directly distributed medicinal product in the importing country. Thus, an application for a parallel import authorisation cannot be rejected solely because no common origin or licensing agreement exists.
Although this condition as such no longer applies, the existence of a common origin or licensing agreement can, however, be used as a tool for assessing whether the required identity exists between the parallel imported medicinal product and the directly distributed medicinal product specified by the parallel importer, see further details below.
If it is not possible to determine whether any common origin or licensing agreement exists, the Danish Medicines Agency will contact the applicant and perhaps the holders of the marketing authorisations in question to obtain more information. Moreover, the identity between the two products can be clarified by examining which companies are responsible for the manufacturing of active substance, production, packaging and release of the medicinal products, respectively.
If the Danish Medicines Agency after several enquiries to the authorities in the exporting country or the relevant companies does not receive the required documentation, the Authority shall have the authority to deny issuing an authorisation for parallel import, in so far as the required and adequate information for the assessment of the application is not available.
It should be noted that the judgment in the Kohlpharma case does not provide access to parallel import, to the extent that directive 2001/83/EC and directive 2001/82/EC contain procedures for the authorisation of a medicinal product. Nor does the judgment open up for parallel import of an applicant's own medicinal product, unless the product concerned has also been granted a marketing authorisation in Denmark.
Parallel importers are responsible for notifying the marketing authorisation holder of the directly distributed medicinal product about their intention of parallel importing the medicinal product in question, cf. section 40 of the Danish executive order on marketing authorisation for medicinal products, etc.
In special circumstances, the Danish Medicines Agency may decide that an application must be submitted towards the directly distributed medicinal product in a way that is different from the usual application procedure. This is the case e.g. if the directly distributed medicinal product has been authorised with a strength that has several package sizes, and where the package sizes contain various quantities of the active substance. In such case, the Authority can decide that a new application for parallel import must be submitted for each package size.
1.4 Parallel import from new member states (Specific mechanism)
In connection with the accession negotiations for the ten new EU member states that joined the EU in 2004, specific transitional provisions were agreed in relation to patent rights, including supplementary protection certificates. The new member states subject to the transitional provisions described in this section are the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia. The holder of the patent or the protection certificate for or the holder of a title to any protection of a medicinal product, which was submitted in a member state at a time when it was not possible to obtain such protection in the above new member states, is in a position to claim the rights awarded by the relevant patent or supplementary protection certificate.
This implies that the holder of the patent or the protection certificate or the holder of the title to any such protection must be able to ensure that their intellectual property rights are not infringed by parallel import to or marketing of the medicinal product in question in any member state in which it is protected by a patent or a supplementary protection certificate, if the medicinal product is parallel imported from one of the new member states.
When a medicinal product, which is patented or which is subject to a supplementary protection certificate, is parallel imported from one of the above member states, it must be stated in the application to the Danish Medicines Agency that the holder of the patent or the protection certificate or the holder of the title to such protection has been notified one month in advance.
Therefore, the parallel importer is under an obligation to tick off the application form to indicate whether notification has been made to the holder of the patent or the protection certificate or to the holder of title to such protection, just as, when submitting the application, the parallel importer must enclose a copy of the letter of notification.
It should be noted that the Danish Medicines Agency is not obligated to pursue any omission of such notification, and that the legal responsibility solely lies with the parallel importer.
1.5 Biological medicinal products
Due to the special nature of biological medicinal products, the Danish Medicines Agency will make a concrete assessment of each individual case of consideration for patient safety and the Authority will possibly require special documentation (for example with regard to HIV and Hepatitis C), cf. section 36 of the Danish executive order on marketing authorisation.
Blood products differ from other biological medicinal products and other medicinal products due to the special risks associated with medicinal products manufactured on the basis of human blood or plasma.
Compared to other biological medicinal products and other medicinal products, medicinal products manufactured on the basis of human blood or plasma have special properties due to the biological nature of the raw material. For example, disease-transmitting agents, especially virus, can contaminate the raw material. Consequently, the safety of these products is determined by control of the raw materials as well as their origin and the manufacturing process, which also comprises removal and inactivation of virus.
In addition to the usual conditions applicable to parallel import, the following conditions must also be fulfilled before an authorisation for parallel import of a blood product can be granted:
- The application must include information proving that the applicant has at its disposal a system which ensures full traceability of each portion of blood or blood components hereof from the donor to the finished product and vice versa
- The application must include information proving that the applicant can ensure traceability between the exporting country and the individual batch of the parallel imported blood product
- The application must include information proving that both the applicant and the Danish Medicines Agency will be informed of any potential risk of seroconversion concerning HIV, hepatitis A, B and C, and vCJD of the individual batch
- The applicant must declare that the data required to ensure full traceability are stored for a minimum of 30 years
In connection with the Danish Medicines Agency's assessment of an application for authorisation for parallel import of a blood product, the Authority will contact the drug regulatory authority in the exporting country and ask for more information about the product. The Authority will ask for information about the Plasma Master File or Files covering the product to ensure that the product from the exporting country and the directly distributed product are covered by the same Plasma Master File or Files and to ensure that they are centrally authorised or authorised under the same decentralised procedure.
Moreover, the Authority will ask the drug regulatory authority to confirm that the authority always follows a procedure ensuring that a rapid alert notification is sent to everybody on the notification list in any situation where a quality defect is classified as Class I or Class II according to the European Medicines Agency's procedure for the handling of Rapid Alerts as a result of quality defects.
Moreover, the Authority will ask the drug regulatory authority to confirm that the authority, in case the donations forming part of the plasma pool appear to be infected with HIV, hepatitis A, B and C, and vCJD or similar, will consider the product as dangerous in accordance with Class I or Class II and that a Rapid Alert will therefore be sent.
1.6 Scope of a marketing authorisation
In the processing of a marketing authorisation application for parallel import, the Danish Medicines Agency places great emphasis on whether the requirements mentioned in section 1.3 are met. If the product subsequently appears not to meet current Danish requirements for obtaining a marketing authorisation, for example in respect of quality, the marketing authorisation will be revoked, cf. sections 14-16 of the Danish Medicines Act and section 37(2) of the Danish executive order on marketing authorisation.
The marketing authorisation is valid for 5 years from the time when the first authorisation for parallel import of the medicinal product concerned was issued. It can be extended 5 years at the time. Renewal applications must be submitted no later than 9 months before the authorisation expires for all of the product’s pharmaceutical forms and strengths under the same name. Usually, the Danish Medicines Agency will consider all parallel import marketing authorisations issued to the same parallel importer under the same name and D.sp.No. at the same time.
The parallel import marketing authorisation only applies to parallel import from the country/countries and the marketing authorisation number(s) in the exporting country that appear from the parallel import authorisation.
When a marketing authorisation for parallel import is issued, so is a summary of product characteristics, which is identical with the summary of product characteristics that applies to the directly distributed medicinal product in relation to which the parallel import takes place, but with relevant editing relative to the original authorisation, such as name and durability. Even though a parallel importer has authorisation to import the same medicinal product from several exporting countries, only one summary of product characteristics for the medicinal product will be issued, and if the qualitative composition of excipients differs from one exporting country to the other, it will appear from the summary of product characteristics.
1.6.1 Withdrawal of marketing authorisation for a directly distributed medicinal product
If the marketing authorisation for a directly distributed medicinal product is withdrawn for safety reasons, any parallel import marketing authorisations will be withdrawn at the same time.
If the marketing authorisation for the directly distributed medicinal product is withdrawn for reasons not related to safety, the parallel import marketing authorisation will not be withdrawn, cf. the decisions in C-15/01 and C-113/01 (the Paranova judgments), unless for reasons of protecting public health, which may justify withdrawal. One example could be a situation where human health is at substantial risk because of the existence of two varieties of the same medicinal product on the market in the importing member state.
If the directly distributed medicinal product is completely withdrawn from the Danish market, which means that it is marketed neither in a different pharmaceutical form nor in a different strength, the parallel imported medicinal product retains the summary of product characteristics of the directly distributed medicinal product existing at the time of withdrawal.
The parallel importer is responsible for keeping updated on whether or not the directly distributed medicine is deregistered. In that case, the parallel importer is responsible for updating all sections of the authorised summary of product characteristics regularly. The parallel importer must revise the summary of product characteristics as changes are being implemented in the exporting country and as relevant safety information becomes available. Any revisions made by a parallel importer are processed by the Danish Medicines Agency as variations.
In connection with renewals, the Danish Medicines Agency provides a PSUR to enable an update of sections 4 (clinical information) and 5 (pharmacological information) of the summary of product characteristics.
In cases where the directly distributed medicinal product is replaced by a product of another pharmaceutical form, the Danish Medicines Agency assesses whether the summary of product characteristics of this pharmaceutical form can also be applied to the parallel imported product. If this is not the case, the Authority assesses whether the summary of product characteristics of another product within the same medicinal product group can be applied. If no suitable summary of product characteristics is available, the Danish Medicines Agency acts as stipulated in situations where the directly distributed medicinal product is completely withdrawn from the Danish market.
1.7 Changes to a parallel imported medicinal product
To eliminate the risk of forgeries, the Danish Medicines Agency requests that the parallel importer focuses on any changes to the parallel imported product, including packaging and labelling.
The parallel importer is obligated to keep updated regularly on any changes to the parallel imported product as well as to keep the Danish Medicines Agency informed accordingly, cf. section 39 of the Danish executive order on marketing authorisation.
If any changes have been made to the parallel imported product’s composition, appearance, primary packing, marketing authorisation holder/manufacturer or authorisation status in the exporting country, etc. in relation to what applied at the time when the marketing authorisation for parallel import into Denmark was issued, the basic position is that the changed products must not be put on the Danish market until the Authority has granted permission for this (however, see below).
If the appearance of a medicinal product is changed, without this resulting from a change in its composition, and in cases when the change only involves engraving, score line and/or tablet form, the product can still be traded until the Danish Medicines Agency may decide otherwise. The parallel importer is obligated to adjust the packaging to ensure that it corresponds to the product from the country of origin at any time.
If the name (including company name) and/or address of the marketing authorisation holder/manufacturer is changed, the medicinal product may continue to be sold. In the case of other insignificant changes, for example changes in item number or change of marketing authorisation holder/manufacturer within the group of companies or the like, where it remains evident that the new holder/manufacturer still belongs to the same group of companies, the product may also continue to be sold.
The parallel importer is responsible for deciding whether a concrete change related to the holder of the marketing authorisation/the manufacturer is significant or not.
If the Danish Medicines Agency has granted its permission for distribution of a medicinal product in cases where the name of the marketing authorisation holder/manufacturer has been changed in the exporting country as the consequence of a merger, the parallel importer may market other products affected by the merger without awaiting a new authorisation. However, the parallel importer must inform the Danish Medicines Agency about all of the company’s products that are affected by the merger.
If the parallel imported medicinal product is given a different marketing authorisation number in the exporting country, the Danish Medicines Agency must be notified without delay to enable the Authority to examine the cause of the change. However, the medicinal product can be traded until the Danish Medicines Agency decides against this.
If the parallel importer wishes to implement other changes to conditions on the basis of which the parallel import authorisation was issued, the changes must be implemented according to the applicable rules on variations.
1.8 Company authorisation
A parallel importer must hold an authorisation to distribute medicinal products, cf. section 39 of the Danish Medicines Act.
Parallel importers wishing to undertake additional labelling, repackaging and/or batch release must also hold a manufacturing authorisation. If the company is to conduct clinical trials of a parallel imported medicinal product, it must have been granted a specific permission in connection with the company authorisation. If additional labelling, repackaging and/or batch release is outsourced to a contract acceptor, the required authorisations must be available.
An application form can be downloaded from the Danish Medicines Agency’s website.
Current rules on good manufacturing and distribution practice for medicinal products must be observed.
If the parallel imported medicinal product is subject to the executive order on euphoriant substances, an application must be submitted for a special authorisation to handle such products.
Under the executive order on distribution of medicinal products, wholesalers must only receive medicinal products from companies holding a valid company authorisation granted by the authorities, and likewise, medicinal products must only be delivered to companies holding a valid company authorisation granted by the authorities.
In the case of supplies of medicinal products obtained from another EU country with the purpose of repacking for parallel import, the parallel importer can base the control on other systems if a control report from the exporting country cannot be obtained. Such other systems must as a minimum involve comparative tests.
Section 2
Application for parallel import marketing authorisation
An application for a parallel import marketing authorisation must be submitted to:
The Danish Medicines Agency
Medicines Licensing & Availability
Axel Heides Gade 1
2300 Copenhagen S
Tel.: +45 4488 9595
Fax: +45 4494 0237
The application must include the following:
- Completed application form (the form can be downloaded from the Danish Medicines Agency’s website).
- Proposed outer and inner packaging and any information to be enclosed in the package.
- Proposed package leaflet in accordance with current rules.
- Original specimen package from the relevant exporting country, including information indicating which exporting country the package originates from, date of submission of the application and name of the parallel importer (the specimen package will not be returned).
- Transport description in cases where the parallel imported medicinal product requires special storage conditions.
In addition, an application must be accompanied by a cover letter containing information on the product name applied for, strength, pharmaceutical form and exporting country.
The summary of product characteristics on which the package leaflet is based, including the date, must be indicated. Moreover, it must be stated whether the package leaflet is updated according to comments received in a previous authorisation for parallel import. If the labelling and package leaflet have been updated since the last submission of documents to the Danish Medicines Agency, the changes must be tracked (track changes).
Other information that may be relevant to the assessment of the application, e.g. that the package leaflet is identical to a previously submitted package leaflet or that a new repacker and/or batch release is used, must appear from the cover letter.
The applicant must keep a copy of the material submitted and the Danish Medicines Agency may, if required, request to see this copy.
2.1 Electronic applications
The application can also be submitted electronically via the Danish Medicines Agency's extranet at www.dkmanet.dk.
If the application is submitted electronically, the subsequent correspondence between the applicant and the Danish Medicines Agency can also take place via www.dkmanet.dk.
Special conditions apply to electronic applications. More information is available at the website of the Danish Medicines Agency.
2.2 Fees
Authorisation fees and annual fees for parallel imported medicinal products are laid down in the executive order on fees (see reference in appendix).
The Danish Medicines Agency collects the fees and charges, and payment must be made in accordance with the Authority's invoicing information.
2.3 Documentation of company authorisation
If the parallel importer already holds a company authorisation from the Danish Medicines Agency which covers the product applied for, it suffices to refer to this authorisation.
If such authorisation has not been granted, an application must be submitted and distribution must not be commenced until the authorisation has been granted.
All secondary packaging sites of the product, including the address, must be indicated in the application form. If an application includes a new secondary packaging site, which the parallel importer has not previously used, a valid GMP certificate must be attached. The GMP certificate must be attached to all applications submitted until the first parallel import authorisation has been granted.
2.4 Language
The application must be in Danish or English.
2.5 Name
Parallel imported medicinal products can be marketed under the same name as the directly distributed medicinal product, relative to which the parallel import takes place, or under a name selected by the parallel importer. The name must be selected in connection with an application for parallel import.
The name applied for must be approved by the Danish Medicines Agency, cf. section 58 of the Danish Medicines Act. As regards choosing a special name, the Danish Medicines Agency refers to the naming policy available at the Authority’s website.
If the parallel importer decides to market the parallel imported medicinal product under a generic name, the generic name may be followed by the name or logo of the holder of the marketing authorisation for the directly distributed medicinal product.
If parallel importers wish to change the name of a parallel imported medicinal product after issuance of their parallel import authorisation, they can apply for another name by submitting a variation application.
It follows from Commission report no. 1444 on reimbursement and the proper use of medicinal products that a situation with different names may cause confusion with patients as well as administrative problems for both doctors and pharmacies. Moreover, different names and name changes may cause products to seem less attractive to doctors and consumers alike.
Considering the patient safety advantages in marketing parallel imported medicinal products under the same name as the directly distributed medicinal product, the Danish Medicines Agency prefers that this name is chosen, unless trademark rights prevent this, cf. below.
The wish to have parallel imported medicinal products marketed under the same name as the directly distributed medicinal product thus stems from the consideration of – through less ambiguity in the naming of medicinal products – creating greater safety for patients and thereby contributing to increased compliance in connection with the use of medicinal products.
With regard to trademark rights, it should be noted that the holder of a trademark right as a point of departure can forbid others, who do not have the trademark holder’s consent, to use the trademark commercially. The holder of a trademark right can, however, not prevent repacking, including renaming or relabelling, if repacking is objectively required because the below conditions, which are inferred from the Court of Justice of the European Union case law, cf. the cases C-427/93, C-429/93 and C-436/93 Bristol-Myers Squibb, are met:
- The holder’s use of the trademark together with the sales system used by the holder, contribute to an artificial division of markets between the member states,
- The repacking cannot affect the original condition of the medicinal product,
- The new package states the names of the manufacturer and the repacker of the medicinal product,
- The repacked presentation form is not of a character that may be harmful to the reputation of the trademark or the trademark holder, and
- The trademark holder is informed about the sale of the repacked medicinal product in advance.
The trademark issue is described in greater detail in a Commission Communication of 30 December 2003 on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted (COM – 2003 – 839). For further information about the five above criteria, refer to point 5 of the Commission Communication, cf. also C-379/97 Pharmacia Upjohn S.A. vs. Paranova A/S.
Moreover, it should be noted that the Danish Medicines Agency does not secure compliance with trademark rights. Thus, authorisation of an application for parallel import does not have effect with regard to trademark rights. Further guidance on trademark rights aspects can be obtained from the Danish Patent and Trademark Office.
2.6 Labelling and package leaflets
Packaging material is to be designed in pursuance of the executive order on labelling etc. of medicinal products (see reference in appendix). Furthermore, reference is made to the applicable guidelines on labelling (see reference in appendix). Thus, a parallel importer must also meet the requirement for Braille writing.
The parallel importer may repack to own boxes/packages (outer packaging) or reuse the original foreign package with additional Danish labelling. Text on the package in a foreign language is acceptable. However, nothing must be stated which is inconsistent with Danish rules, including the parallel import authorisation. Foreign packaging material may be covered with a Danish label. If the original foreign package is used, any foreign bar code etc. must be covered.
The parallel importer is responsible for ensuring that nothing must be stated which is inconsistent with current rules and guidelines as well as the parallel import authorisation.
Bundling of two or more packages with tape, shrink wrapping or the like will usually not be permitted.
Furthermore, the Danish Medicines Agency would like to emphasise the following elements of its practice:
In the case of a parallel imported medicinal product which deviates from the directly distributed medicinal product in colour, appearance, taste, etc. or, in the case of an injection product, which deviates from the directly distributed medicinal product in the content of preservatives, the Danish Medicines Agency recommends that the outer packaging is provided with information indicating the deviation.
Blister cards indicating day of the week are accepted, even if the labelling does not correspond to the dosage approved in Denmark, as long as both the outer packaging and the blister card are provided with a text to the effect that the dosage prescribed by the doctor must be followed and that, if required, the labelling indicating day of the week should be disregarded.
The Danish Medicines Agency has accepted parallel imported tablets without a score line, even though the original directly distributed tablets have a score line, as long as it is indicated on the outer packaging that the tablets have no score line.
If the inner packaging is marked with a product name which deviates from the approved product name of the parallel imported medicinal product, the outer packaging must be provided with a text informing the user about the deviation concerned. Moreover, the approved product name must be indicated on the inner packaging, and the principal rule is that it must be at least as prominent as the foreign product name.
It is particularly important to note that the expiry date on the outer and inner packaging must correspond to the expiry date approved for the parallel imported medicinal product in Denmark.
In addition, it should be stressed that the batch number of the medicinal product must be printed on both the outer and the inner packaging. To ensure uniform batch numbering, it is solely the batch number assigned to the parallel imported product that is to be printed on the package.
In case of parallel import of injection products, repackaging and relabelling must be assessed closely, particularly in case of transparent labels. The additional labelling on the inner packaging should not be placed outside the limits of the existing labelling from the exporting country, because it is often necessary for the user to make a visual inspection of the product before use.
Parallel imported medicinal products must be provided with Danish package leaflets drawn up in accordance with the rules laid down in the executive order on labelling etc. of medicinal products. The package leaflet must only contain information about the pharmaceutical form(s) and/or strength(s) which the parallel importer holds a marketing authorisation for.
2.7 Shelf life
When the parallel import authorisation is issued, the shelf life is determined in accordance with the shelf life approved in the exporting country. If the exporting country’s shelf life is longer than the one applicable in Denmark to the directly distributed medicinal product, a concrete, medical assessment will be made in every single case in order to decide whether it is deemed safe to apply the shelf life of the exporting country in Denmark.
If the shelf life in the exporting country is changed, a similar change can be approved in Denmark via a variation application, and, as mentioned above, the approval is subject to a concrete, medical assessment.
2.8 Case handling times
The Danish Medicines Agency will not initiate the processing of an application until the Authority has received the full body of required application material.
From the time when the Danish Medicines Agency receives an application for marketing authorisation for parallel import, there is a start-up phase of up to 14 days, where the application is validated. After this, the procedure is initiated for the application. The Danish Medicines Agency aims to process applications for marketing authorisation within 60 days. The 60 days are considered as net time, i.e. it excludes the time that the Authority spends waiting for information, for example from the exporting country or the applicant.
In order to obtain the shortest processing time possible, it should be attempted that suggestions for labelling and package leaflets are prepared thoroughly pursuant to the above criteria and that no changes are requested in already submitted application material.
Section 3
Related issues
3.1 Clinical trials
In connection with clinical trials of parallel imported medicinal products, refer to section 3.3 of the Danish Medicines Agency’s guidelines on notification of clinical trials of medicinal products in humans.
3.2 Free samples of medicinal products
Free samples of parallel imported medicinal products can be handed out on the same conditions as those applying to directly distributed medicinal products pursuant to the rules in the executive order on medicinal product samples.
3.3 Reporting of adverse reactions
Holders of a marketing authorisation for parallel import of a medicine are not comprised by the rules in sections 4(1)-(5) of the executive order on monitoring of adverse reactions from medicinal products2) as concerns having an adverse reaction specialist and establishing and operating an adverse reaction system, but they must be equipped to receive enquiries concerning suspected adverse drug reactions and exposure reactions occurring from the use of the parallel imported medicinal product, cf. section 4(6) of the executive order.
Holders of a marketing authorisation for parallel import are comprised by the reporting rules and must report any suspected adverse reactions and exposure reactions occurring in Denmark and must also report any suspected serious/unexpected adverse reactions and all suspected exposure reactions occurring in a country outside the EU/EEA (third country), cf. sections 6 and 7 of the executive order. In this respect, parallel importers are subject to the same conditions as marketing authorisation holders of directly distributed medicinal products.
The holder of a marketing authorisation for a medicine for human use must submit reports electronically to the adverse reaction database (the EudraVigilance database) established by the European Medicines Agency in respect of all suspected serious adverse reactions occurring in Denmark reported to it by a healthcare professional, a patient or a relative, or those which the holder of the marketing authorisation can reasonably be assumed to have knowledge of from scientific literature or safety studies. The report must be submitted no later than 15 days after the marketing authorisation holder concerned became aware of the occurrence, cf. section 6(1) of the executive order.
The holder of a marketing authorisation for a medicine for human use must submit reports electronically to the EudraVigilance database in respect of all suspected non-serious adverse reactions occurring in Denmark reported to it by a healthcare professional, a patient or a relative, or those which the holder of the marketing authorisation can reasonably be assumed to have knowledge of from scientific literature or safety studies. The report must be submitted no later than 90 days after the marketing authorisation holder concerned became aware of the occurrence, cf. section 6(2) of the executive order.
The marketing authorisation holder of a medicine for veterinary use must report to the Danish Medicines Agency all suspected serious adverse reactions and all suspected exposure reactions occurring in Denmark reported to it by a healthcare professional, a patient, a relative or the animal’s owner, or those which the holder of the marketing authorisation can reasonably be assumed to have knowledge of from scientific literature or safety studies. The report must be submitted immediately and in no case later than 15 days after the marketing authorisation holder became aware of the occurrence, cf. section 6(3) of the executive order.
The holder of a marketing authorisation for a medicine for human use must report to the European Medicines Agency all suspected serious adverse reactions occurring in a country outside the EU/EEA (third country) reported to it by a healthcare professional, a patient or a relative. The report must be submitted immediately and in no case later than 15 days after the marketing authorisation holder concerned became aware of the occurrence, cf. section 7(1) of the executive order.
The holder of a marketing authorisation for a medicine for veterinary use must report to the Danish Medicines Agency and the European Medicines Agency all suspected serious unexpected adverse reactions and all suspected exposure reactions occurring in a country outside the EU/EEA (third country) reported to it by a healthcare professional, a patient, a relative or the animal’s owner. The report must be made immediately and in no case later than 15 days after the marketing authorisation holder became aware of the occurrence. Reports originating from relatives and the animal’s owner should, however, only be reported to the Danish Medicines Agency, cf. section 7(2) of the executive order.
Any enquiries about adverse reactions that a holder of a marketing authorisation for parallel import of a medicine has received, cf. section 4(6) which are not reported pursuant to sections 6 and 7, must be forwarded to the Danish Medicines Agency upon the agency’s request immediately, however at least every sixth months in the first two years from the date of actual marketing of the medicine, and then once a year in the subsequent two years, and every three years thereafter, cf. section 10 of the executive order. The same provision provides that the holder of a marketing authorisation for parallel import of a medicinal product is exempt from the rules on submission of periodic safety update reports (PSURs).
3.4 Relationship with other legislation
In connection with the issuance of a parallel import marketing authorisation, the Danish Medicines Agency does not ensure that trademark or patent rights are not violated. Such matters should be settled in a civil action.
As regards product liability, reference is made to the general rules relating to this, cf. the Danish product liability act, under which an action for damages may be brought against the manufacturer and any middle man in pursuance of the rules laid down in the act.
3.5 Withdrawal of the previous guidelines
The Danish Health Authority’s guideline no. 9081 of 29 January 2014 on parallel import of medicines is repealed.
The Danish Medicines Agency, 27 February 2018
Mette Aaboe Hansen
/Stine Gregers Hørsøe
Appendix 1
Table of contents
Section 1
Scope of and conditions for parallel import
1.1 Definitions
1.2 Introduction
1.3 Conditions for parallel import
1.4 Parallel import from new member states (Specific mechanism)
1.5 Biological medicinal products
1.6 Scope of a marketing authorisation
1.7 Changes to a parallel imported medicinal product
1.8 Company authorisation
Section 2
Application for parallel import marketing authorisation
2.1 Electronic applications
2.2 Fees
2.3 Documentation of company authorisation
2.4 Language
2.5 Name
2.6 Labelling and package leaflets
2.7 Shelf life
2.8 Case handling times
Section 3
Related issues
3.1 Clinical trials
3.2 Free samples of medicinal products
3.3 Reporting of adverse reactions
3.4 Relationship with other legislation
3.5 Withdrawal of the previous guidelines
Appendices
Appendix 2
Danish Medicines Act: Consolidation act order no. 506 of 20 April 2013.
Executive order on labelling etc. of medicinal products: Executive order no. 869 of 21 July 2011 on the labelling etc. of medicinal products.
(Danish title: Bekendtgørelse nr. 869 af 21. juli 2011 om mærkning m.m. af lægemidler)
Executive order on fees: Executive order no. 733 of 8 June 2017 on fees payable for medicinal products and companies, etc.
(Danish title: Bekendtgørelse nr 733 af 8. juni 2017 om gebyrer for lægemidler og lægemiddelvirksomheder m.v.)
Executive order on medicinal product samples: Executive Order no. 1244 of 12 December 2005 on the supply of medicinal product samples.
(Danish title: Bekendtgørelse nr. 1244 af 12. december 2005 om udlevering af lægemiddelprøver)
Executive order on GMP: Executive order no. 1358 of 18 December 2012 on manufacture and import of medicinal products and intermediary products
(Danish title: 'Bekendtgørelse nr. 1358 af 18. december 2012 om fremstilling og indførsel af lægemidler og mellemprodukter')
Executive order on GDP: Executive Order no. 1359 of 18 December 2012 on distribution of medicinal products.
(Danish title: Bekendtgørelse nr. 1359 af 18. december 2012 om distribution af lægemidler)
Euphoriant substances: Danish executive order no. 557 of 31 May 2011 on euphoriant substances, as amended most recently by executive order no. 730 of 12 June 2017.
(Danish title: Bekendtgørelse nr. 557 af 31. maj 2011 om euforiserende stoffer, senest ændret ved bekendtgørelse nr. 730 af 12. juni 2017)
Marketing authorisation: Danish executive order no. 1239 of 12 December 2005 on marketing authorisation of medicinal products, etc., as amended most recently by executive order no. 1282 of 12. December 2012.
(Danish title: Bekendtgørelse nr. 1239 af 12. december 2005 om markedsføringstilladelse til lægemidler m.m., senest ændret ved bekendtgørelse nr. 1282 af 12.december 2012)
Danish Drug Standards: current edition.
Guidelines on notification of clinical trials of medicinal products in humans, Danish Medicines Agency, October 2006.
(Danish title: Vejledning om anmeldelse af kliniske forsøg med lægemidler på mennesker, Lægemiddelstyrelsen oktober 2006)
Guidelines on notification of clinical trials of veterinary medicinal products in animals, Danish Medicines Agency, July 2003.
(Danish title: Vejledning om anmeldelse af kliniske forsøg med veterinærlægemidler på dyr, Lægemiddelstyrelsen juli 2003)
Guidelines on drawing up package leaflets for medicinal products for human use, current edition.
(Danish title: Vejledning vedrørende udarbejdelse af indlægssedler for lægemidler til human brug, gældende udgave)
Commission Communication of 30 December 2003: Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted.
The De Peijper judgment, European Court of Justice, 20 May 1976, case C-104/75, cf. 1976, p. 613.
The Paranova judgments, European Court of Justice, 8 May 2003, cases C-15/01 and C-113/01.
The Kohlpharma judgment, European Court of Justice, 30 April 2004, case C-112/02.
Official notes
1) In addition to the EU countries, this includes Norway, Iceland and Lichtenstein.
2) Executive order no. 1191 of 6 November 2017 on monitoring of adverse reactions from medicinal products.