Date: 2021.03.09

All CMDh guidance documents refer to the use of English language dossiers and English language product information texts. At the end of the procedures, the RMS should provide the final English texts for SmPC, PL and labelling. This is also required for providing the texts and, if applicable, the public assessment report in the MRI-PI. Therefore, English texts shall be submitted in a clean version as well as in a version with changes highlighted and evaluated in procedures that include only German-speaking countries as well as in procedures that continue with German-speaking MS alone due to the expiry of marketing authorisations in other CMSs. For type IA and type IB variations the national translations have to be submitted together with the English texts in the application; they are evaluated in parallel with the English texts during the procedure.

Variations submitted after 01.05.2021 without the English texts on SmPC, PL and Labelling will therefore not be accepted.

Date: 2023.03.24

According to the CMDh Best Practice Guidances for Variations

the MAH should provide the RMS with the final agreed common texts (english) via e-mail before the "end of procedure".
With "EoP Notification", the RMS circulates the texts to the CMS and to the MAH.
In parallel, the clean documents are uploaded to CTS for transfer to the MRI index of the HMA.

Recommended approach in detail:

• The final agreed SmPC/PL/labelling texts should be sent as "tracked" and "clean version" (docx file) via e-mail to the responsible BfArM contact immediately after the last deadline for CMS comments (approx. on procedure Day 81 - in case of reduced/extended timetable on Day 26/111).
• For procedures that can already be approved on Day 60 (30/90) (= positive PVAR + no CMS comments), the submission should take place on approx. Day 56 (20/86).
• A separate file should be submitted per strength/dosage form and type (SmPC/PIL). If the adopted texts for different strengths/dosage forms and type (PI/SmPC/PIL) are in a common file, this can be submitted as a common file. In a worksharing procedure, separate texts should be submitted for each integrated MRP/DCP procedure.

• The naming of the files should preferably be as follows:

  
  Procedure number_active substance_FINAL_type(SmPC/PIL)_cv/hv
  Example:

  DE_1234_1_II_2_Diclofenac_FINAL_SmPC_cv

  DE_1234_1-2_WS_0815_Ibuprofen_FINAL_PI_hv

Date: 2013.12.11

If an update of the texts in line with the QRD templates (labelling, PIL and SmPC) is submitted in addition to a Type IB or Type II variation, this should be stated clearly in the cover letter and under “Precise scope and background for change” in the application form. In this constellation no fees will be charged. No further variation submission is required, nor is reference to a variation code necessary. No fees will be charged if this change is made in the context of a renewal. Further information is available on the website of the CMDh under variations, Question 3.16.

Date: 2013.12.11

If the implementation of the explanatory statements on additional monitoring and ADR reporting is submitted in addition to a Type IB or Type II variation of change category C, this should be stated clearly in the cover letter and under “Precise scope and background for change” in the application form. In this constellation no fees will be charged. No further variation submission is required, nor is reference to a variation code necessary. No fees will be charged if this change is made in the context of a renewal. Further information is available on the website of the CMDh under variations, Question 2.11.a.

Date: 2013.12.11

If only the adaption of the texts in order to be in line with the current QRD template without any further changes (a single variation) is submitted, this is considered to be a Type IB variation with a change category C.I.z. for which fees will be charged.

Date: 2013.12.11

If only the implementation of the explanatory statements on additional monitoring and ADR reporting without any further changes (a single variation) is submitted, this is considered to be a Type IAIN with variation a change category C.I.z. in accordance with Article 5 recommendations. In this case fees will be charged. For further information please click here for the CMDh recommendations.

Date: 2013.12.11

It is possible to submit an adaption of the texts together with Type IA or Type IAIN variations. This change is classified as a Type IB variation with the change category C.I.z. which is subject to fees. This classification is a grouping of a variation Type IB with a variation Type IA/ IAIN. and the general regulations for groupings of national variations have to be followed. Further information can be found in the announcement Bekanntmachung vom 12. Juli 2013.

Date: 2013.12.11

It is possible to submit the implementation of the explanatory statements on additional monitoring and ADR reporting together with Type IA or Type IAIN variations. This change is classified as a Type IAIN variation with the change category C.I.z. in accordance with the Article 5 recommendation. This classification is a grouping of a variation Type IAIN with a variation Type IA/ IAIN and the general regulations for groupings of national variations have to be followed. Further information can be found in the announcement Bekanntmachung vom 12. Juli 2013.

Yes, according to the CMDh position papier on the use of mobile scanning of package leaflets and labelling, the following options are available:

1. A website of the national regulatory authority
2. Dedicated pages set up by the marketing authorisation holder for the mobile devices in the Member States, which do not require the mobile devices to be linked to the website of their national competent authorities
3. A linked, stand-alone PDF document

If the pharmaceutical company is taking responsibility for publishing the digital package leaflet, e.g. via the platform https://www.gebrauchsinformation4-0.de, the higher federal authorities would not object to the inclusion of the following text under the heading "Further sources of information".

„Die vorliegende gedruckte Gebrauchsinformation enthält die für die Sicherheit des Arzneimittels relevanten Informationen. Gebrauchsinformationen von Arzneimitteln werden fortlaufend überarbeitet und an den aktuellen wissenschaftlichen Erkenntnisstand angepasst. Daher wird im Auftrag und in eigener Verantwortung unseres Unternehmens zusätzlich eine aktuelle digitale Version dieser Gebrauchsinformation unter https://www.gebrauchsinformation4-0.de von der Roten Liste Service GmbH <andere werbefreie Homepage> bereitgestellt und kann auch mit einem geeigneten mobilen Endgerät/Smartphone durch einen Scan <des linearen Barcodes> <des Matrix-2D-Codes/QR-Codes> <über Near Field Communication (NFC)> <auf der Arzneimittel-Packung> <in dieser Gebrauchsinformation> mit der App [Namen angeben, z. B. „Gebrauchsinformation 4.0 (GI 4.0)]“, abgerufen werden.“

The submission can either be made via a so-called "P-Procedure", as only the package leaflet is affected, or as an additional change ("editorial change") in the context of a type IB or type II variation concerning the product information.

The European Medicines Agency (EMA) is the competent authority for centrally authorised medicinal products. The BfArM recommends to contact the EMA in case of questions.

As Type IA notifications are simple validation procedures, the procedure will normally be completed directly after validation so that no "in process" phase will exist.

Due to the newly created link between the AMIS database with adjoining IT systems, data were automatically transferred into AMIS. This transfer triggered the status information. However, the formal closure of these procedures still has to be executed manually. Due to the large number of procedures this may lead to delays. Thus, the a.m. status information is not related to the amended regulation.

In cases where variation applications also lead to changes in the product information (Package Leaflet and SmPC), the amended version of these texts has to be submitted immediately to the relevant national competent authority in accordance with Sections 11 (1a) and 11a (3) AMG.
For the submission of final texts the BfArM is planning to introduce a simplified electronic procedure via PharmNet.Bund. In the transitional phase, the submission should be made within 3 weeks after the end of procedure of the variation according to the conventions of the AMG Submission Ordinance. In this procedure, only clean versions have to be submitted as pdf-documents. The technical prerequisites as well as the fixed rules and format provisions according to the current information for the implementation of the AMG Submission Ordinance under www.bfarm.de have to be regarded. Please observe that the exact reference to the variation application is made as follows:

Example:
Table – Naming of metadata within attribut.txt

Basically, yes. However, the BfArM strongly recommends switching to the eCTD or NeeS formats, as only structured submissions like with eCTD ensure that the processing is as smooth and resource-sparing as possible.

Provided the submission is made via the PharmNet.Bund and/or CESP portals, no signature is necessary on these forms. The authorisation procedure and the login data needed for this purpose which are part of the PharmNet.Bund and/or CESP portals are considered as adequate substitute for the signature. The BfArM therefore strongly recommends not submitting scanned application forms.

EU Electronic Application Forms can definitively be used as an alternative. In this case, the scanned signature will be accepted in any format, as the authorisation procedure which is part of the PharmNet.Bund and/or CESP portal is considered an adequate substitute for the signature. Here, the scanned signature ensures that data cannot be modified subsequently. Therefore, the Electronic Application Forms should not be submitted without the scanned signature.

The PharmNet.Bund “Online Variation Submission” application offers the possibility of sending a request for correction. For this purpose you have to select the option “list sent notifications” from “Work list” under “Notification sent”. From this list you can choose the variation by clicking on “Correction request” and then “Continue”; the next step is to enter the reason: “correction of CESP submission number”. The command “Submit” then sends the request for correction to the BfArM which will usually be confirmed the next working day. After release of the data record you can select the variation by choosing “list sent notifications for correction”, perform the changes and resend the modified variation.

Further Information can be found in Chapters 6.7 and 6.8 of the German version of the manual: Handbuch "Elektronische Änderungsanzeigen"

A variation is not required, if no changes to the content of the marketing authorisation dossier are necessary for reformatting into the eCTD format and if a corresponding confirmation is given.

Please also consider the FAQs concerning eSubmissions - Information on the electronic submission ("e-only") of follow-up applications.

If content modifications are required to implement the eCTD format, these modifications should be classified according to the variation guideline.

For processing purely national variations there will first be a conditional fee, i.e. the BfArM explicitly reserves the right to request fees after an amendment of the AMG Fees Ordinance. The exact amount of the fees will be determined by the legislator. It will be adapted to personnel and material expenditures and will therefore probably be somewhere between the costs for variations with Germany as RMS and those for variations with Germany as CMS. The invoices will be circulated after the amended AMG Fees Ordinance has come into force.

Yes. These variations are categorised as “horizontal groupings” according to Article 13.d.2) of Regulation 712/2012/EC. However, when submitting such variations to the BfArM they should not be submitted as a grouping but as a collective submission. This is marked by an “S” in the procedure number. In these cases, the tickbox “grouping of variations” in the application form does not have to be marked.

A grouping should be marked in the application form in cases where several changes are grouped.

It is intended to adapt the announcement of the BfArM of 12 July 2013 accordingly in the next update.

All minor notifications of type IA and type IAIN may be grouped in one application without any relation to each other, if the group includes only type IA and type IAIN.

Following the recommendation pursuant to Article 5 of the Variation Regulation, the adaption to the model texts should be classified as variation C.I z.

If an appropriate model text regarding strength and dosage form exists, a minor variation Type IA is acceptable together with a declaration that the text has been adapted word by word.
If the model text is different in strength or dosage form or if deviations from the model texts are intended, a variation Type IB should be submitted. All deviations should be marked and justified.

Adaptions of texts to conform with the excipient guidelines (changes in the SmPC and corresponding PIL/labelling) are to be submitted as variations Type IB classification category C.I.z.

According to the general grouping rules, a text adaptation to excipient guidelines submitted as a variation of Type IB classification category C.I.z, can be submitted together with variations of Type IA or IA (IN) classification categories A or C.

If an additional variation Type lB category C or a variation Type ll category C is submitted, a text adaptation to excipient guidelines can be included in the course of this variation.
No separate variation submission is necessary nor is reference to a variation code required. It is sufficient to describe this change in the texts in the application form under "Precise scope and background for change". In this constellation, the adaptation to excipient guidelines is free of charge. For further information please also refer to the Questions & Answers of the CMDh, Variations, Question 3.16.

Adaptions of texts to conform with the MedDRA terminology (changes in the SmPC and corresponding PIL/labelling) are to be submitted as a variations Type IB classification category C.I.z.

According to the general grouping rules, a text adaptation to MedDRA terminology submitted as a variation of Type IB classification category C.I.z, can be submitted together with variations of Type IA or IA (IN) classification categories A or C.

If an additional variation Type lB category C or a variation Type ll category C is submitted, a text adaptation to MedDRA terminology can be included in the course of this variation.
No separate variation submission is necessary nor is reference to a variation code required. It is sufficient to describe this change in the texts in the application form under "Precise scope and background for change". In this constellation, the adaptation to MedDRA terminology is free of charge. For further information please also refer to the Questions & Answers of the CMDh, Variations, Question 3.16.

When adapting product informations to updated CCDS, each change aspect which triggers an update in the CCDS should be mentioned in the scope of the application form and should be classified according to the variation guideline.
The identified change aspects can be combined in a grouped variation application.
The term “change aspect” includes the following items: e.g. literature investigations, database investigations, adaption to the Core Safety Profile, adaption to reference texts etc.

The reference medicinal product is defined in Art. 10(2)(a) of Dir. 2001/83/EC. This is the medicinal product, to which a marketing authorisation application according to 10(1) or 10(3), resp., Dir. 2001/83/EC refers to.

If there are changes in the product texts of the reference medicinal product, this variation category can be used for the referring marketing authorisations to adapt their product texts.

The reference medicinal product should be clearly specified within the scope of the application form –stating the medicinal product name, marketing authorisation holder and marketing authorisation number and the confirmation that the reference product is the reference product from the original application.

The relevant excerpt from the marketing authorisation application form should be appended as proof. Furthermore, the concerned product texts of the reference medicinal product should be appended to the application.

We refer to the following Q/A of the CMDh :

Question 4.14
How can a generic MA be adapted to the most current version of the SmPC, if the results of several procedures, e.g. PRAC/ PhVWP recommendations and PSUR worksharing, have to be considered?
Answer:
The applicant has to submit one variation application according to C.I.3.a, b or z for each single change applied for. The single change is defined by one data package triggering the variation. All these single changes may be combined in one grouped application, see also Examples for acceptable and not acceptable groupings for MRP / DCP products, http://www.hma.eu/96.html.
It is not acceptable to wait for the originator to have implemented all these changes and subsequently submit a single variation C.I.2.a in order to adapt to the originator,nor is it possible to include all the changes in a Company Core Data Sheet (CCDS) and to submit a single variation of type II under category C.I.4.

The change in the package leaflet can be applied for together with the change in the SmPC in one variation application.
The following Art. 5 recommendation is applicable, that a type IB variation is required for these cases:

The classification for dispensing of medicinal products is regulated by the Ordinance on the Prescription Requirement for Medicinal Products ("Arzneimittelverschreibungs-Verordnung", AMVV) as well as the Ordinance on Pharmacy-only Medicinal Products and Medicinal Products Sold outside Pharmacies ("Verordnung über apothekenpflichtige und freiverkäufliche Arzneimittel", AMVerkRV). If the dispensing classification of a substance is altered by way of an ordinance without requiring changes other than the dispensing classification itself in the informative texts, this is to be notified by way of a national variation in accordance with Section 29 sub-section 1 of the Medicinal Products Act (Arzneimittelgesetz, AMG). Any adjustments to the QRD template that are necessary as a result of the altered dispensing classification can also be indicated. The corresponding updated texts are to be submitted. Should further changes become necessary at the same time, the adaptation to the ordinance can be notified exceptionally within the next national Type IB variation or Type II variation category C.

If the dispensing classification for a substance is only altered with regard to individual aspects (e.g. indications, pack sizes) and this also entails alterations of these aspects themselves, a variation stating the appropriate category/categories in accordance with the European Commission's guidelines is to be submitted. It should be borne in mind that only one dispensing classification per medicinal product is permissible. Submission of the variation is only permissible after the ordinance for changing the dispensing classification has entered into force. This applies regardless of whether the medicinal product is marketed/placed on the market at this time.

In the case of medicinal products that are declassified by ordinance for distribution outside of pharmacies, this fact is to be notified in accordance with Section 29 sub-section 1 AMG and the updated texts are to be submitted. If this is not (or no longer) a medicinal product that is only allowed to be dispensed to the consumer by pharmacies, the specification "apothekenpflichtig" (pharmacy-only drug) is to be deleted from the informative texts.

If the smallest pack size on the market is used as a sample, the competent authority does not need to be notified of this. However, compliance with the requirements of Section 47 sub-section 3 of the German Medicinal Products Act ("Arzneimittelgesetz", AMG) remains unaffected by this.

Using a smaller pack size as a sample than that authorised is also possible. However, such variations in pack size have to be submitted in accordance with the rules of the variation regulation. Should you subsequently wish to change back to the former arrangement, this shall also be notified appropriately.

The inclusion of information on already authorised indications protected by a patent due to expiration of this patent should be applied for as a type IB variation C.I.z since this implies a change of the product texts.

As variations in the marketing status (distribution or non-distribution in Germany) of licensed pack-sizes are variations to the informative texts, they are to be classified as type IB variation category C.I.z.

The BfArM recommends including the following sentence in the informative texts of all licensed pack-sizes:

„Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.“
("It is possible that not all pack-sizes are placed on the market.")

Should this information not yet be included in the texts, it can be added by way of a type IB variation category C.I.z.

For editorial changes as well as adjustments to the current QRD template and the special features list (Besonderheitenliste)/Excipients Guideline, please refer to the CMDh Q&A for Variations #3.16.

The procedure described above is also explicitly applicable to variations of purely national marketing authorisations.

The answer is given under topic Purely National Variation Procedures

No. The assessment within a variation procedure is restricted to the documentation which is required in accordance with the Guideline on the details of the various categories of variations and further relevant guidance.

Consequently, only documentation in connection with the variation should be submitted by the applicant. Moreover, only such documents which support the applied variation will be assessed by the competent authority.

In view of this, please note that only those changes are deemed to have been notified properly that are listed under section 3 "Types of Changes“ in the application form and are thus subject to the decision of the variation application.

The present/proposed section in the application form should list the complete information on the present as well as the proposed manufacturer of an active substance and/or finished product including their manufacturing sites with full addresses and their respective functions according to SPOR-RMS/SPOR-OMS. Should there have been no changes with regard to manufacturer, manufacturing sites including full addresses, and respective functions they should nevertheless be listed again in the “proposed” section.

Correct implementation and corresponding processing in the competent regulatory authority’s medicinal product database can only be ensured if the information provided is complete and comprehensible.

According to the CMDh Q&A to Variations #3.16, the EMA Post-authorisation Guidance Q&A on Editorial Changes has to be considered.

This guidance is also explicitly applicable to variations of purely national marketing authorisations.

1. The following are feasible as editorial changes:

• the addition of headings.
• the rearrangement of existing content without changing its content.
• the adaptation of information, provided that proof can be given that the correct data has already been registered and approved.
• orthographic and grammatical corrections.

Please note that editorial changes can only be made up to the fourth segment of the dossier part affected by the change.
Example: If the indicated change affects module 3.2.S.2.1, only editorial changes from modules 3.2.S.2.1 to 3.2.S.2.7 can be submitted.

The application form should also contain the justification of the editorial changes required in the EMA Post-Authorisation Guidance as well as a tabular comparison of the changes. It must also be confirmed in the application form that the editorial changes do not alter the content of the dossier beyond those changes notified.

2. The following are not feasible as editorial amendments:

• the deletion of specification parameters or manufacturing descriptions, etc.
• updates to adapt the dossier to current manufacturing processes, etc.
• the correction of incorrect descriptions, e.g. the change from 'solution' to 'suspension'
• adaptation of former 'in-house' methods to Ph. Eur.
  (list not conclusive)

Please note that the examples under 2. should only be regarded as examples.

Should an editorial change be observed during the processing of a variation application that cannot be implemented as such according to the applicable criteria, you may be asked at any time to classify and notify the change in accordance with the Classification Guideline.

In this context, it should be noted that requests for corrections always lead to a delay in the validation phase, as the request cannot be forwarded immediately to the relevant department. Therefore, in your own interest, please carefully check each editorial change in advance for plausibility on the basis of the above criteria.

A change of the reference medicinal product of the initial marketing authorisation is generally not possible. Please refer to the CMDh Questions & Answers on Variations No. 3.30 (cf. https://www.hma.eu/20.html).

However, in order to update the product information, reference can be made to the authorisation of another EU/EEA reference medicinal product within the same global marketing authorisation (GMA), if this update is made in order to ensure the safety of the medicinal product.

In cases where the texts of this marketing authorisation have not been harmonised with the initial marketing authorisation, a Type II variation C.I.2.b is required to adapt the product information.

If the texts are harmonised, adaptation is possible via a Type IB variation C.I.2.a.

According to Section 11 (1) sentence 9 AMG, the marketing authorisation holder is further obliged to keep the texts up-to-date with the current state of scientific knowledge. For this purpose, the results of all procedures concerning the marketing authorisation, in particular PRAC recommendations, conclusions from PSUR worksharing procedures or from PSUR Single Assessments (PSUSA) must be implemented and the individual amendments must be applied for in accordance with the respective applicable amendment category pursuant to the Variation Guideline.
Further changes are to be applied for as Type II Variations C.I.4 (cf. the above-mentioned CMDh Questions & Answers on Variations 4.14 and 4.19).

Data on the resistance situation of systemically available antibiotics in Germany is regularly reassessed in the Z.A.R.S. project and is considered in the resistance table for Section 5.1 of the SmPC. In addition, the annually updated data from EUCAST (European Committee on Antimicrobial Susceptibility Testing) are processed and the relevant limits in relation to the respective approved indications of an antibiotic are presented in the EUCAST table.

Information on marketing authorisations from national procedures:

Adaptations to the current resistance data in section 5.1 of the Summary of Product Characteristics have to be submitted as a Type IB variation category C.I.z, unless the marketing authorisation holder is a participant in the Z.A.R.S. project. The update of the EUCAST table is included in the variation. In cases of adjustments to the reference product, the adaption to the resistance data has to be submitted as a separate variation category.

Participants in the Z.A.R.S. project update the resistance data with a Type IA variation with the variation category C.I.z. With each variation, relevant proof of participation in the project must be submitted. The variation is free of charge. Therefore, variations from Z.A.R.S. participants for updating the resistance data should be submitted separately. In cases of adaptations to the reference product, the Z.A.R.S. data can be updated without a separate variation category, but this should be mentioned in the scope.

Information on marketing authorisations from MRP and DCP:

Adaptations to the current resistance data in section 5.1 of the Summary of Product Characteristics have to be submitted as a Type IB variation category C.I.z.
For participants of the Z.A.R.S. project with submission of the relevant evidence, this change is free of charge in DE.
If participants of the Z.A.R.S. project add Z.A.R.S. data exclusively to the non-official part of the DE Summary of Product Characteristics, a national IA variation category C.I.z is to be submitted.

In the case of a mixed EMA worksharing procedure, national marketing authorizations (from MRP/DCP/NAT) are incorporated in addition to one or more centralised marketing authorizations. In these cases, the review of the translated text changes will only be performed in the context of the EMA Post-Opinion Linguistic Review, i.e. exclusively for the centralised marketing authorizations concerned.
The result of this review, which is approved by the European Commission, is then transferred in the same wording to the national marketing authorizations, i.e. DCP, MRP and purely national marketing authorizations. The transfer is done under the responsibility of the marketing authorization holder and there is no separate submission of a draft version required.
However, a confirmation is requested to the procedure management, that the amended text passages in the national marketing authorizations correspond to the opinion of the worksharing procedure and the translations adopted by the European Commission. For the national marketing authorizations involved in the procedure, a request to submit the amended product information to the "PIT" portal will be sent via PharmNet.Bund after the positive adoption of national translations in the EMA worksharing procedure.

As of 4 August 2013, the rules laid down in Chapter IIa of Commission Regulation (EC) No 1234/2008 of 24 November 2008 ("Variation Regulation") as amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 continue to be applicable for the submission and assessment of variations to the terms of purely national marketing authorisations.

The following medicinal products are exempted from the scope of this regulation:

• Authorised homeopathic medicinal products for human use authorised or regarded as authorised prior to 1 January 1998
• Registrations of homeopathic medicinal products pursuant to Section 38 AMG
• Registrations of traditional herbal medicinal products pursuant to Section 39 a-d AMG
• Parallel imports
• Standard marketing authorisations pursuant to Section 36 AMG

For variations to the terms of marketing authorisation of medicinal products outside the scope of Commission Regulation (EC) No 1234/2008, Section 29 of the German Medicinal Products Act (AMG) remains applicable.

The following changes are regarded as outside the scope of Commission Regulation (EC) No 1234/2008 and therefore are to be submitted as purely national variations pursuant to Section 29 (1) AMG:

• Transfer of marketing authorisation to a new holder
• Change regarding co-marketing
• Change regarding the local representative and/or distributor
• Change in legal status resulting from adoption or change in the legal regulation on the legal status of medicinal products as long as no further amendments of the product information are necessary
• Editorial changes to the national package leaflet, immediate and secondary packaging only

Further information on purely national variation procedures in accordance with Section 29 AMG is available on our homepage under Variations national

The regulation applies to:

• Purely national marketing authorisations
• Marketing authorisations following a mutual recognition procedure or a decentralised procedure (MRP / DCP)
• Parallel import marketing authorisations
• German standard marketing authorisations

The adaptation has to be submitted as national change notification pursuant to Section 29 (1) or for a German standard marketing authorisation pursuant to Section 67 (5) of the German Medicinal Products Act (AMG). The correct implementation in accordance with Section 2 (3) of the AnalgetikaWarnHV should either be confirmed or alternatively a labelling draft of the outer packaging or the immediate packaging should be enclosed.

It is recommended to submit the change notification via PharmNet.Bund.

Medicinal products authorised before 1 July 2018, and affected by the AnalgetikaWarnHV may be placed on the market without the required warning 2 years after the regulation became effective, which means until 30 June 2020.

All medicinal products authorised after 1 July 2018, and affected by the AnalgetikaWarnHV may only be placed on the market if the labelling contains the requested warning.