EMA Write PMS API Implementation Guide - Enrichments
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CodeSystem: Documentation

Official URL: http://spor.ema.europa.eu/v1/lists/200000003964 Version: 1.0.0
Active as of 2025-04-04 Computable Name: DocumentationCs

Documentation

This Code system is referenced in the content logical definition of the following value sets:

Generated Narrative: CodeSystem 200000003964

version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000

This case-sensitive code system http://spor.ema.europa.eu/v1/lists/200000003964 defines the following codes:

CodeDisplay
200000004202 A declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application as responsible for batch release.
200000004203 A declaration by the Qualified Person (QP) responsible for batch certification stating that the active substance manufacturer(s) referred to in the marketing authorisation operate in compliance with the detailed guidelines on good manufacturing practice for starting materials. A single declaration may be acceptable under certain circumstances — see the note under variation No B.II.b.1.
200000004204 A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the changes to the manufacturing methods are only those necessitated by scale-up or downscaling, e.g. use of different-sized equipment, that the change does not adversely affect the reproducibility of the process, that it is not the result of unexpected events arising during manufacture or because of stability concerns and that the specifications of the active substance/intermediates remain the same.
200000004205 A declaration from the marketing authorisation holder or the ASMF holder as appropriate that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem.
200000004206 A declaration from the marketing authorisation holder or the ASMF holder, where applicable, that the synthetic route quality control procedures and specifications of the active substance and of the starting material/reagent/intermediate in the manufacturing process of the active substance (if applicable) are the same as those already approved.
200000004207 A declaration from the marketing authorisation holder or the ASMF Holder, where applicable, that there is no change in qualitative and quantitative impurity profile or in physico-chemical properties, that the synthetic route remains the same and that the specifications of the active substance or intermediates are unchanged.
200000004208 A declaration that the proposed Summary of Product Characteristics, Labelling and Package Leaflet is identical for the concerned sections to that annexed to the Commission Decision or to the agreement reached by the CMDh (as applicable).
200000004209 A declaration that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem.
200000004210 A declaration that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation and that the available data did not indicate a problem.
200000004211 A document including the identification (name and address) of the current PMF Holder (transferor) and the identification (name and address) of the person to whom the transfer is to be granted (transferee) together with the proposed implementation date — signed by both companies.
200000004212 A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name and/or address is mentioned.
200000004213 Amendment of product information (where applicable).
200000004214 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate) including revised product information as appropriate.
200000004215 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), and of the approved Active Substance Master File (where applicable), including a direct comparison of the present process and the new process.
200000004216 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate).
200000004217 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), if applicable.
200000004218 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a description of the analytical methodology and a summary of validation data.
200000004219 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a description of the analytical methodology, a summary of validation data, revised specifications for impurities (if applicable).
200000004220 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a detailed drawing of the current and proposed situation, and including revised product information as appropriate.
200000004221 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a detailed drawing or written description of the current and new appearance, and including revised product information as appropriate.
200000004222 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including a direct comparison of the present process and the new process.
200000004223 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including description, detailed drawing and composition of the container or closure material, and including revised product information as appropriate.
200000004224 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including description, detailed drawing and composition of the device material and supplier where appropriate, and including revised product information as appropriate.
200000004225 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including identification method for any new colorant, where relevant, and including revised product information as appropriate.
200000004226 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including revised product information as appropriate.
200000004228 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate). This must contain results of appropriate real time stability studies (covering the entire shelf life) conducted in accordance with the relevant stability guidelines on at least two pilot scale batches of the finished product in the authorised packaging material and/or after first opening or reconstitution, as appropriate.
200000004229 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate). This must contain results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on at least two pilot or production scale batches of the active substance in the authorised packaging material and covering the duration of the requested retest period or requested storage conditions.
200000004230 Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format).
200000004231 Amendment of the relevant section(s) of the dossier.
200000004232 Amendment of the relevant section(s) of the dossiers including the introduction of the new studies to investigate the capability of manufacturing steps to inactivate/reduce adventitious agents.
200000004233 Amendment of the relevant section(s) of the dossiers.
200000004234 An expert statement outlining all the changes introduced with the certified PMF and evaluating their potential impact on the finished products including product specific risk assessments.
200000004235 An expert statement outlining all the changes introduced with the certified VAMF and evaluating their potential impact on the finished products including product specific risk assessments.
200000004236 Appropriate data on the new packaging (comparative data on permeability, e.g. for O 2 , CO 2 moisture).
200000004237 Appropriate data on the new packaging (e.g. comparative data on permeability, e.g. for O 2 , CO 2 moisture), including a confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic materials and objects in contact with foodstuffs.
200000004238 Assurance on GMP or ISO compliance of the site where the sterilisation of the containers is performed.
200000004239 Attached to the cover letter of the variation application: A reference to the agreement of the competent authority (in the case of marketing authorisations granted under the centralised procedure, the CHMP).
200000004240 Attached to the cover letter of the variation application: a reference to the Commission Decision concerned or to the agreement reached by the CMDh (as applicable) with the annexed Summary of Product Characteristics, Labelling or Package Leaflet.
200000004241 Attached to the cover letter of the variation application: A reference to the Commission Decision concerned.
200000004242 Attached to the cover letter of the variation application: A reference to the list of medicinal products that are subject to additional monitoring.
200000004243 Attached to the cover letter of the variation application: A reference to the relevant decision of the competent authority.
200000004244 Attached to the cover letter of the variation application: EMA/NCA request, if applicable.
200000004245 Attached to the cover letter of the variation application: proof of authorisation of the legal status change (e.g. reference to the Commission Decision concerned).
200000004246 Attached to the cover letter of the variation application: reference to the agreement/assessment of the competent authority.
200000004247 Attached to the cover letter of the variation application: The relevant decision of the competent authority.
200000004248 Batch analysis data (in a comparative tabular format) for at least two batches (minimum pilot scale) of the active substance from the current and proposed manufacturers/sites.
200000004249 Batch analysis data (in a comparative tabulated format) of at least two batches (minimum pilot scale) of the excipient manufactured according to the old and the new process.
200000004250 Batch analysis data (in a comparative tabulated format) on a minimum of one batch manufactured to both the currently approved and the proposed process. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).
200000004251 Batch analysis data (in a comparative tabulated format) on a minimum of one production batch manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the MAH if outside specifications (with proposed action).
200000004252 Batch analysis data (in a comparative tabulated format) on a minimum of one production batch of the active substance or intermediate as appropriate, manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).
200000004253 Batch analysis data (in a comparative tabulated format) on two production batches of the relevant substance for all tests in the new specification and additionally, where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch. For herbal medicinal products, comparative disintegration data may be acceptable.
200000004254 Batch analysis data (in comparative tabular format) of at least two batches (minimum pilot scale) manufactured according to the currently approved and proposed process.
200000004255 Batch analysis data on one production batch and two pilot-scale batches simulating the production process (or two production batches) and comparative data on the last three batches from the previous site; batch data on the next two production batches should be available on request or reported if outside specifications (with proposed action).
200000004256 Batch analysis data on two batches of the immediate packaging for all specification parameters.
200000004257 Batch analysis data on two production batches (3 production batches for biological excipients) of the excipient for all specification parameters.
200000004258 Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the active substance for all specification parameters.
200000004259 Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the finished product for all specification parameters.
200000004260 Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the relevant substance for all specification parameters.
200000004261 Batch analysis data on two production batches for all tests in the new specification.
200000004262 Change management protocol related to the active substance.
200000004263 Change management protocol related to the finished product.
200000004264 Comparative dissolution data on at least one pilot batch of the current and proposed dimensions (no significant differences regarding comparability see the relevant (Human or Veterinary) guidance on Bioavailability). For herbal medicinal product comparative disintegration data may be acceptable.
200000004265 Comparative table of current and proposed in-process tests and limits.
200000004266 Comparative table of current and proposed in-process tests.
200000004267 Comparative table of current and proposed specifications.
200000004268 Comparative table of current and proposed specifications, if applicable.
200000004269 Comparative table of the current and proposed immediate packaging specifications, if applicable.
200000004270 Comparative validation results or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.
200000004271 Comparison of the current and proposed immediate packaging specifications, if applicable.
200000004272 Confirmation of the transfer of the complete PMF documentation since the initial PMF certification to the transferee — signed by both companies.
200000004273 Confirmation that stability studies have been done to the currently approved protocol. The studies must show that the agreed relevant specifications are still met.
200000004274 Copy of approved and new (if applicable) specifications of the excipient.
200000004275 Copy of approved end of shelf life finished product specification and where applicable, specifications after dilution/reconstitution or first opening.
200000004276 Copy of approved release and end-of-shelf life specifications if relevant.
200000004277 Copy of approved release and end-of-shelf life specifications.
200000004278 Copy of approved specifications of the active substance (and of the intermediate, if applicable).
200000004279 Copy of approved specifications of the active substance.
200000004280 Copy of approved specifications of the finished product.
200000004281 Copy of the current (updated) Ph. Eur. Certificate of Suitability.
200000004282 Copy of the EMA letter of acceptance of the new (invented) name.
200000004283 Copy of the latest PMF Certificate page ‘EMA Plasma Master File (PMF) Certificate of compliance with Community legislation’.
200000004284 Copy of the modified manufacturing authorisation, if available; or a formal document from a relevant official body (e.g. Chamber of Commerce, or if not available, from a Regulatory Agency) in which the new name and/or address is mentioned.
200000004285 Data to demonstrate accuracy, precision and compatibility of the device.
200000004286 Data to demonstrate that the new excipient does not interfere with the finished product specification test methods, if appropriate.
200000004287 Data to demonstrate the suitability of the monograph to control the substance, e.g. a comparison of the potential impurities with the transparency note of the monograph.
200000004288 Declaration from the manufacturer or the marketing authorisation holder of the material that it is purely of vegetable or synthetic origin.
200000004289 Declaration that any change should be within the range of currently approved limits. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.
200000004290 Declaration that relevant stability studies have been started under ICH/VICH conditions, as appropriate, (with indication of the batch numbers concerned) and relevant stability parameters have been assessed in at least one pilot scale or industrial scale batch and at least 3 months satisfactory stability data are at the disposal of the applicant at time of notification and that the stability profile is similar to the currently registered situation.
200000004291 Declaration that stability studies will be conducted in accordance with the relevant guidelines for products where stability parameters could be affected. Data to be reported only if outside specifications (with proposed action).
200000004292 Declaration that the change is in accordance with the approved change management and that the study results meet the acceptance criteria specified in the protocol. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.
200000004293 Declaration that the PMF Certificate and Evaluation Report are fully applicable for the authorised product, PMF holder has provided the PMF Certificate, Evaluation report and PMF dossier to the MAH (where the MAH is different to the PMF holder), the PMF Certificate and Evaluation Report replace the previous PMF documentation for this Marketing Authorisation.
200000004294 Declaration that the remaining pack-size(s) is/are consistent with the dosage regimen and duration of treatment and adequate for the dosing instructions as approved in the summary of product characteristics.
200000004295 Declaration that the remaining product presentation(s) are adequate for the dosing instructions and treatment duration as mentioned in the summary of product characteristics.
200000004296 Declaration that the VAMF Certificate and Evaluation Report are fully applicable for the authorised product, VAMF holder has submitted the VAMF Certificate, Evaluation report and VAMF dossier to the MAH (where the MAH is different to the VAMF holder), the VAMF Certificate and Evaluation Report replace the previous VAMF documentation for this Marketing Authorisation.
200000004297 Demonstration of GMP approval of the changes, which should be available at the time of implementation.
200000004298 Description of the design space in tabular format, including the variables (material attributes and process parameters, as appropriate) and their proposed ranges.
200000004299 Detailed description for the proposed change.
200000004300 Details of any new analytical method and summary of validation data.
200000004301 Details of any new analytical method and validation data, where relevant.
200000004302 Details of any new non-pharmacopoeial analytical method and validation data, where relevant.
200000004303 Details of the sterilisation method should be provided and in the event that the method does not use the reference conditions stated in the Ph. Eur., validation data should be provided.
200000004304 Either a Ph. Eur. Certificate of Suitability for any new component of animal susceptible to TSE risk or where applicable, documentary evidence that the specific source of the TSE risk material has been previously assessed by the competent authority and shown to comply with the scope of the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products.
200000004305 Either a TSE Ph. Eur. Certificate of Suitability for any new source of material or, where applicable, documentary evidence that the specific source of the TSE risk material has previously been assessed by the competent authority and shown to comply with the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products.
200000004306 Epidemiological data for viral markers related to the blood/plasma collection centre covering the last 3 years. For newly opened centre(s) or in case no data are yet available, a declaration that epidemiological data will be provided at the time of the next annual update(s).
200000004307 For a site within the EU/EEA: Attach copy of manufacturing authorisation(s) or where no manufacturing authorisation exists a certificate of GMP compliance issued within the last 3 years by the relevant competent authority. For a manufacturing site outside the EEA where an operational GMP mutual recognition agreement (MRA) exists between the country concerned and the EU: a GMP certificate, issued within the last 3 years by the relevant competent authority.
200000004308 For centralised procedure only: contact details of new contact person in the EU/EEA for product defects and recalls, if applicable.
200000004309 For changes to process parameter(s) that have been considered to have no impact on the quality of the finished product, declaration to this effect reached in the context of the previously approved risk assessment.
200000004310 For devices for medicinal products for human use, proof of CE marking.
200000004311 For semi-solid and liquid formulations in which the active substance is present in non-dissolved form, appropriate validation data including microscopic imaging of particle size distribution and morphology or any other appropriate imaging technique.
200000004312 For semi-solid and liquid products in which the active substance is present in non-dissolved form: appropriate validation of the change including microscopic imaging of particles to check for visible changes in morphology; comparative size distribution data by an appropriate method.
200000004313 For solid dosage forms, comparative dissolution profile data of at least two pilot scale batches of the finished product in the new and old composition. For herbal medicinal products, comparative disintegration data may be acceptable.
200000004314 For solid dosage forms: dissolution profile data of one representative production batch and comparative data of the last three batches from the previous process; data on the next two full production batches should be available on request or reported if outside specification (with proposed action). For herbal medicinal products, comparative disintegration data may be acceptable.
200000004315 For veterinary medicines intended for use in food producing animal species, proof that the excipient is classified according to Article 14(2)(c) of Regulation (EC) No 470/2009 or, if not, justification that the excipient does not have pharmacological activity at the dose at which it is administered to the target animal.
200000004316 i) If the new manufacturing site uses the active substance (AS) as a starting material - A declaration by the QP at the site responsible for batch release that the AS is manufactured in accordance with GCP for starting materials. ii) In addition, if the new manufacturing site is located within the EU/EEA and uses the AS as a starting material - A declaration by the QP of the new manufacturing site that the AS used is manufactured in accordance with GCP for starting materials.
200000004317 If applicable, amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including revised product information as appropriate.
200000004318 If the manufacturing site and the primary packaging site are different, conditions of transport and bulk storage should be specified and validated.
200000004319 In case of a change in the headspace or a change in the surface/volume ratio, a declaration that the required stability studies have been started under ICH/VICH conditions (with indication of the batch numbers concerned) and that, as relevant, the required minimum satisfactory stability data were at the disposal of the applicant at time of implementation for a Type IA notification and time of submission of a Type IB notification, and that the available data did not indicate a problem.
200000004320 In case of an addition of a manufacturing site, the variation application form should clearly outline the ‘present’ and ‘proposed’ manufacturers as listed in section 2.5 of the application form.
200000004321 In case of change in the name of the holder of the Active Substance Master File holder, updated ‘letter of access’.
200000004322 Justification for change in name.
200000004323 Justification for not submitting a new bioequivalence study according to the current Note for Guidance on The Investigation of Bioavailability and Bioequivalence.
200000004324 Justification for not submitting a new bioequivalence study according to the relevant (Human or Veterinary) guidance on Bioavailability.
200000004325 Justification for not submitting a new bioequivalence study according to the relevant (Human, Veterinary) Guideline on Bioavailability, if appropriate.
200000004326 Justification for the change/choice of excipients etc. must be given by appropriate development pharmaceutics (including stability aspects and antimicrobial preservation where appropriate).
200000004327 Justification for the deletion of the device.
200000004328 Justification for the deletion of the target species.
200000004329 Justification for the deletion, including a statement regarding alternative means to obtain the solvent/diluent as required for the safe and effective use of the medicinal product.
200000004330 Justification for the new specification parameter and the limits.
200000004331 Justification for the new/remaining pack-size, showing that the new/remaining size is/are consistent with the dosage regimen and duration of treatment as approved in the summary of product characteristics.
200000004332 Justification for the proposed change(s).
200000004333 Justification for the proposed deletion.
200000004334 Justification from the MAH or ASMF Holder as appropriate for the new in-process test and limits.
200000004335 Justification from the MAH or ASMF Holder as appropriate of the new specification parameter and the limits.
200000004336 Justification from the marketing authorisation holder or the ASMF Holder, as appropriate, of the new specification parameter and the limits.
200000004337 Justification of the new in-process test and limits.
200000004338 Justification of the new specification parameter and the limits.
200000004339 Justification that the studies do not modify the risk assessment.
200000004340 Justification/risk assessment from the marketing authorisation holder or the ASMF Holder, as appropriate, that the in-process parameter is non-significant, or that the in-process parameter is obsolete.
200000004341 Justification/risk assessment from the marketing authorisation holder or the ASMF Holder, as appropriate, that the in-process tests are non-significant, or that the in-process tests are obsolete.
200000004342 Justification/risk assessment showing that the in-process test is non-significant or that it is obsolete.
200000004343 Justification/risk assessment showing that the parameter is non-significant or that it is obsolete.
200000004344 Latest version of the DDPS and, where applicable, latest version of the product specific addendum. These should include for changes to the QPPV a) summary CV of the new QPPV, b) proof of QPPV EudraVigilance registration, and c) a new statement of the MAH and the QPPV regarding their availability and the means for notification of adverse reactions signed by the new QPPV and the MAH, and reflecting any other consequential changes, e.g. to the organisation chart.
200000004345 Letter of Authorisation including contact details of the person responsible for communication between the competent authority and the PMF holder — signed by the transferee.
200000004346 Letter of Undertaking to fulfil all open and remaining commitments (if any) — signed by the transferee.
200000004347 List of testing centre(s) where the kit is currently used and a list of testing centre(s) where the kit will be used.
200000004348 List of testing site(s) where the kit is used.
200000004349 PMF Certificate and Evaluation Report.
200000004350 Proof of acceptance (by WHO) or copy of the ATC (Vet) Code list.
200000004351 Proof of acceptance by WHO or copy of the INN list. If applicable, proof that the change is in line with the Ph. Eur. For herbal medicinal product, declaration that the name is in accordance with the Note for Guidance on Quality of Herbal Medicinal Products, and with the guideline on declaration of herbal substances and herbal preparations in (traditional) herbal medicinal products.
200000004352 Proof of CE marking and if a measuring function is intended the proof of CE marking should also include the 4 digit notified body number.
200000004353 Proof of establishment of the new holder (Excerpt of the commercial register and the English translation of it) — signed by both companies.
200000004354 Proof of GMP approval of the changes, which should be available at the time of implementation.
200000004355 Proof that the proposed site is appropriately authorised for the pharmaceutical form or product concerned.
200000004356 Proof that the proposed site is appropriately authorised for the pharmaceutical form or product or manufacturing operation concerned.
200000004357 PSMF number (if available)
200000004358 Reference of the application/procedure and product in which the change(s) were accepted.
200000004359 Reference to an assessment / Copy of assessment document from a previous procedure where the temperature of use has been agreed.
200000004360 Reference to the application/procedure and product in which the DDPS was assessed previously.
200000004361 Reference to the approved change management protocol.
200000004362 Results from product and process development studies (including risk assessment and multivariate studies, as appropriate) demonstrating that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the finished product has been achieved.
200000004363 Results of the appropriate Ph. Eur tests demonstrating equivalence in characteristics/correct dosing.
200000004364 Results of the studies performed in accordance with the approved change management protocol.
200000004365 Revalidation studies have been performed in case of sterile products terminally sterilised. The batch numbers of the batches used in the revalidation studies should be indicated, where applicable.
200000004366 Revised frequency and/or date of submission of the PSUR (for medicinal products authorised via the centralised procedure, the full set of annexes, including the revised Annex II should be provided).
200000004367 Revised Product Information (and Annex A, if applicable).
200000004368 Revised product information.
200000004369 Sample of the new product, where applicable (see Notice to Applicants Requirements for samples in the Member States).
200000004370 Samples of the finished product where applicable (see NTA, Requirements for samples in the Member States).
200000004371 Samples of the new container/closure where applicable (see NTA, Requirements for samples in the Member States/EMA).
200000004372 Samples of the new device where applicable (see NTA, Requirements for samples in the Member States).
200000004373 Signed declaration that the change does not involve a change of the quality system within the blood establishment.
200000004374 Signed declaration that there is no change in the list of the collection centres.
200000004375 Statement that the centre is working under the same conditions as the other centres belonging to the blood establishment, as specified in the standard contract between blood establishment and PMF holder.
200000004376 Statement that the storage centre is working following the same SOPs as the already accepted establishment.
200000004377 Statement that the testing is performed following the same SOPs and/or test methods as already accepted.
200000004378 Study of equivalence of the materials and the impact on production of the final material and impact on behaviour (e.g. dissolution characteristics) of the finished product.
200000004379 Suitable evidence to confirm compliance of the water used in the final steps of the synthesis of the active substance with the corresponding requirements on quality of water for pharmaceutical use.
200000004380 Summary of the pharmacovigilance system, or update of the relevant elements (as applicable): - Proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance and a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC. - Contact details of the QPPV, Member States in which the QPPV resides and carries out his/her tasks - PSMF location
200000004381 The batch numbers of the tested batches having the proposed batch size.
200000004382 The change should not lead to substantial amendments of the product information.
200000004383 The changes introduced during the referral procedure should be clearly highlighted in the submission.
200000004384 The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies demonstrating where relevant that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the active substance has been achieved.
200000004385 The medicinal product can still be accurately delivered.
200000004386 The new Detailed Description of the Pharmacovigilance System (DDPS).
200000004387 The new device is compatible with the medicinal product.
200000004388 The proposed measuring or administration device must accurately deliver the required dose for the product concerned in line with the approved posology and results of such studies should be available.
200000004389 The results of stability studies that have been carried out under ICH/VICH conditions, on the relevant stability parameters, on at least one pilot or industrial scale batch, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action).
200000004390 The results of stability studies that have been carried out under ICH/VICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved retest period (with proposed action).
200000004391 The results of stability studies that have been carried out under ICH/VICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved shelf life (with proposed action).
200000004392 The section “present/proposed” is filled out completely and correctly.
200000004393 The updated ASMF must be submitted by the ASMF holder (open and closed part to NCA, open part to MAH), the variation as such has to be submitted by the marketing authorisation holder.
200000004394 The validation results should be provided.
200000004395 The variation application form should clearly outline the ‘present’ and ‘proposed’ finished product manufacturers as listed in section 2.5 of the application form.
200000004396 The variation application form should clearly outline the ‘present’ and ‘proposed’ finished product manufacturers, importer, batch control/testing and batch release sites as listed in section 2.5 of the application form for marketing authorisation.
200000004397 The variation application form should clearly outline the ‘present’ and ‘proposed’ manufacturers as listed in section 2.5 of the application form for marketing authorisations.
200000004398 The variation application form should clearly outline the ‘present’ and ‘proposed’ PMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other PMFs to which the medicinal product refers even if they are not the subject of the application.
200000004399 The variation application form should clearly outline the ‘present’ and ‘proposed’ VAMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other VAMFs to which the medicinal product refers even if they are not the subject of the application.
200000004400 Update of the relevant section of the dossier.
200000004401 Updated relevant sections and annexes of the PMF dossier, including a list of all the blood establishments using this transport organisation, a summary of the system in place to ensure that the transport is performed under appropriate conditions (time, temperature and GMP compliance) and confirmation that transport conditions are validated.
200000004402 Updated relevant sections and annexes of the PMF dossier, including detailed description of the new conditions, confirmation of validation of storage/transport conditions and the name of the blood establishment(s) where the change takes place (if relevant).
200000004403 Updated relevant sections and annexes of the PMF dossier, including the name of container, manufacturer, anticoagulant solution specification, confirmation of CE-mark and the name of the blood establishments where the container is used.
200000004404 Updated relevant sections and annexes of the PMF dossier, including updated information on testing as requested in the ‘Guideline on the scientific data requirements for a PMF’.
200000004405 Updated relevant sections and annexes of the PMF dossier.
200000004406 Updated relevant sections of the PMF dossier, including the rationale for introduction or extension of inventory hold period, the sites where the inventory hold takes place and for changes to procedure, a decision tree including new conditions.
200000004407 Updated relevant sections of the PMF dossier.
200000004408 VAMF Certificate and Evaluation Report.
200000004409 Where applicable, a document providing information of any materials falling within the scope of the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products including those which are used in the manufacture of the active substance/excipient.
200000004410 Where applicable, for active substance, a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the QP of each of the manufacturing authorisation holders listed in the application as responsible for batch release.
200000004411 Where appropriate, comparative dissolution profile data for the finished product of at least two batches (minimum pilot scale). For herbal medicinal products, comparative disintegration data may be acceptable.
200000004412 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.
200000004413 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the active substance complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.
200000004414 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products comparative disintegration data may be acceptable.
200000004415 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch manufactured using the current and new in-process tests. For herbal medicinal products, comparative disintegration data may be acceptable.
200000004416 Where appropriate, proof must be provided that no interaction between the content and the packaging material occurs (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic material and objects in contact with foodstuffs.
200000004417 Where relevant the batch numbers, corresponding batch size and the manufacturing date of batches (≥ 3) used in the validation study should be indicated or validation protocol (scheme) be submitted.
200000004418 Where relevant, a commitment of the manufacturer of the active substance to inform the MA holder of any changes to the manufacturing process, specifications and test procedures of the active substance.
200000004419 Where relevant, the batch numbers, corresponding batch size and the manufacturing date of batches (≥ 3) used in the validation study should be indicated and the validation data presented, or validation protocol (scheme) to be submitted.
200000004420 Written confirmation from the manufacturer of the finish product stating verification of compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practices.
200000023186 Written confirmation from the manufacturer of the finished product stating verification of compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practices.
200000023187 A declaration from the marketing authorisation holder or the ASMF holder that the synthetic route quality control procedures and specifications of the active substance and of the starting material/reagent/intermediate in the manufacturing process of the active substance are the same as those already approved. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023188 Batch analysis data (in a comparative tabular format) for at least two batches (minimum pilot scale) of the active substance from the current and proposed manufacturers/sites.
200000023189 The variation application form should clearly outline the “present” and “proposed” manufacturers as listed in the application form for marketing authorisation.
200000023190 Proof that the proposed site is appropriately authorised for the pharmaceutical form or product or manufacturing operation concerned (SEE FULL DESCRIPTION IN GUIDELINE)
200000023191 Amendment of the approved Active Substance Master File, including a direct comparison of the present process and the new process.
200000023192 Batch analysis data (in comparative tabular format) of at least two batches (minimum pilot scale) manufactured according to the currently approved and proposed process.
200000023193 Copy of approved specifications of the active substance.
200000023194 A declaration from the ASMF Holder that there is no change in qualitative and quantitative impurity profile or in physico-chemical properties, that the synthetic route remains the same and that the specifications of the active substance or intermediates are unchanged.
200000023195 The batch numbers of the tested batches having the proposed batch size.
200000023196 Batch analysis data (in a comparative tabulated format) on a minimum of one production batch of the active substance or intermediate as appropriate, manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).
200000023197 Copy of approved specifications of the active substance (and of the intermediate, if applicable).
200000023198 Comparative table of current and proposed in-process tests.
200000023199 Details of any new non-pharmacopoeial analytical method and validation data, where relevant.
200000023200 Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the active substance for all specification parameters.
200000023201 Justification from the MAH or ASMF Holder as appropriate for the new in-process test and limits.
200000023202 Comparative table of current and proposed specifications.
200000023203 Details of any new analytical method and validation data, where relevant.
200000023204 Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the relevant substance for all specification parameters.
200000023205 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the active substance complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.
200000023206 Justification from the MAH or ASMF Holder as appropriate of the new specification parameter and the limits.
200000023207 Description of the analytical methodology, a summary of validation data, revised specifications for impurities (if applicable).
200000023208 Comparative validation results, or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.
200000023209 Appropriate data on the new packaging (e.g. comparative data on permeability e.g. for O2, CO2 moisture), including a confirmation that the material complies with relevant pharmacopoeial requirements or legislation of the Union on plastic materials and objects in contact with foodstuffs.
200000023210 Where appropriate, proof must be provided that no interaction between the content and the packaging material occurs (e.g. no migration of components of the proposed material into the content and no loss of components of the product into the pack), including confirmation that the material complies with relevant pharmacopoeia requirements or legislation of the Union on plastic material and objects in contact with foodstuffs.
200000023211 The results of stability studies that have been carried out under VICH conditions, on the relevant stability parameters, on at least two pilot or industrial scale batches, covering a minimum period of 3 months, and an assurance is given that these studies will be finalised, and that data will be provided immediately to the competent authorities if outside specifications or potentially outside specifications at the end of the approved retest period (with proposed action).
200000023212 Comparison of the current and proposed immediate packaging specifications, if applicable.
200000023213 Batch analysis data on two batches of the immediate packaging for all specification parameters.
200000023214 Justification from the marketing authorisation holder or the ASMF Holder, as appropriate, of the new specification parameter and the limits.
200000023215 Results of appropriate real time stability studies, conducted in accordance with the relevant stability guidelines on at least two (three for biological medicinal products) pilot or production scale batches of the active substance in the authorised packaging material and covering the duration of the requested re-test period or requested storage conditions.
200000023216 Confirmation that stability studies have been done to the currently approved protocol. The studies must show that the agreed relevant specifications are still met.
200000023217 The design space has been developed in accordance with the relevant European and international scientific guidelines. Results from product, process and analytical development studies demonstrating where relevant that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the active substance has been achieved. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023218 Description of the Design space in tabular format, including the variables (material attributes and process parameters, as appropriate) and their proposed ranges.
200000023219 Detailed description for the proposed change.
200000023220 Change management protocol related to the active substance.
200000023221 Declaration that the change is in accordance with the approved change management and that the study results meet the acceptance criteria specified in the protocol. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.
200000023222 Detailed drawing or written description of the current and new appearance.
200000023223 Samples of the finished product where applicable.
200000023224 Detailed drawing of the current and proposed situation.
200000023225 Comparative dissolution data on at least one pilot batch of the current and proposed dimensions (no significant differences regarding comparability see the relevant guidance on bioavailability/bioequivalence). For herbal medicinal product comparative disintegration data may be acceptable.
200000023226 Justification for not submitting a new bioequivalence study according to the relevant guidance on Bioavailability/bioequivalence.
200000023227 Identification method for any new colorant, where relevant.
200000023228 Sample of the new product, where applicable.
200000023229 Either a Ph. Eur. Certificate of Suitability for any new component of animal susceptible to TSE risk or where applicable, documentary evidence that the specific source of the TSE risk material has been previously assessed by the competent authority and shown to comply with the scope of the current Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023230 For solid dosage forms, comparative dissolution profile data of at least two pilot scale batches of the finished product in the new and old composition. For herbal medicinal products, comparative disintegration data may be acceptable.
200000023231 If intended for use in food producing animal species, proof that the excipient is classified according to Article 14(2)(c) of Regulation (EC) No 470/2009 of the European Parliament and the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, or, if not, justification that the excipient does not have pharmacological activity at the dose at which it is administered to the target animal.
200000023232 Proof that the proposed site is appropriately authorised for the pharmaceutical form or product or manufacturing operation concerned. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023233 Where relevant, the batch numbers, corresponding batch size and the manufacturing date of batches (larger than/equal to 3) used in the validation study should be indicated and the validation data presented, or validation protocol (scheme) to be submitted.
200000023234 The variation application form should clearly outline the “present” and “proposed” finished product manufacturers as listed in the application form.
200000023235 Copy of approved release and end-of-shelf life specifications if relevant.
200000023236 Batch analysis data on one production batch and two pilot-scale batches simulating the production process (or two production batches) and comparative data on the last three batches from the previous site; batch data on the next two production batches should be available on request or reported if outside specifications (with proposed action).
200000023237 For semisolid and liquid formulations in which the active substance is present in non-dissolved form, appropriate validation data including microscopic imaging of particle size distribution and morphology or any other appropiate imaging technique.
200000023238 Declaration by the Qualified Person. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023239 Direct comparison of the present process and the new process.
200000023240 For semi-solid and liquid products in which the active substance is present in non-dissolved form: appropriate validation of the change including microscopic imaging of particles to check for visible changes in morphology; comparative size distribution data by an appropriate method.
200000023241 For solid dosage forms: dissolution profile data of one representative production batch and comparative data of the last three batches from the previous process; data on the next two full production batches should be available on request or reported if outside specification (with proposed action). For herbal medicinal products, comparative disintegration data may be acceptable.
200000023242 For changes to process parameter(s) that have been considered to have no impact on the quality of the finished product, declaration to this effect reached in the context of the previously approved risk assessment.
200000023243 Copy of approved release and end-of-shelf life specifications.
200000023244 Batch analysis data (in a comparative tabulated format) on a minimum of one batch manufactured to both the currently approved and the proposed process. Batch data on the next two full production batches should be made available upon request and reported by the marketing authorisation holder if outside specification (with proposed action).
200000023245 Declaration that relevant stability studies have been started under VICH conditions, as appropriate, (with indication of the batch numbers concerned) and relevant stability parameters have been assessed. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023246 Batch analysis data (in a comparative tabulated format) on a minimum of one production batch manufactured to both the currently approved and the proposed sizes. Batch data on the next two full production batches should be made available upon request and reported by the MAH if outside specifications (with proposed action).
200000023247 Where relevant the batch numbers, corresponding batch size and the manufacturing date of batches (larger than/equal to 3) used in the validation study should be indicated or validation protocol (scheme) be submitted.
200000023248 The validation results should be provided.
200000023249 The results of stability studies that have been carried out under VICH conditions. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023250 Comparative table of current and proposed in-process tests and limits.
200000023251 Batch analysis data on two production batches (3 production batches for biologicals, unless otherwise justified) of the finished product for all specification parameters.
200000023252 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch manufactured using the current and new in-process tests. For herbal medicinal products, comparative disintegration data may be acceptable.
200000023253 Justification of the new in-process test and limits.
200000023254 Batch analysis data on two production batches (3 production batches for biological excipients) of the excipient for all specification parameters.
200000023255 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products comparative disintegration data may be acceptable.
200000023256 Justification for not submitting a new bioequivalence study according to the relevant Guidance on bioavailability/bioequivalence, if appropriate.
200000023257 Justification of the new specification parameter and the limits.
200000023258 Description of the analytical methodology, a summary of validation data, revised specification for impurities (if applicable).
200000023259 Comparative validation results or if justified comparative analysis results showing that the current test and the proposed one are equivalent. This requirement is not applicable in case of an addition of a new test procedure.
200000023260 Declaration from the manufacturer or the marketing authorisation holder of the material that it is purely of vegetable or synthetic origin.
200000023261 Study of equivalence of the materials and the impact on production of the final material and impact on behaviour (e.g. Dissolution characteristics) of the finished product.
200000023262 Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable.
200000023263 Justification of the new specification parameter and the limits.
200000023264 Appropriate data on the new packaging (comparative data on permeability e.g. for O2, CO2 moisture).
200000023265 Comparative table of the current and proposed immediate packaging specifications, if applicable.
200000023266 Samples of the new container/closure where applicable.
200000023267 Description, detailed drawing and composition of the container or closure material.
200000023268 Re-validation studies have been performed in case of sterile products terminally sterilised. The batch numbers of the batches used in the re-validation studies should be indicated, where applicable.
200000023269 In case of a change in the headspace or a change in the surface/volume ratio, a declaration that the required stability studies have been started under VICH conditions. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023270 Justification for the new pack-size, showing that the new size is consistent with the dosage regimen and duration of treatment as approved in the summary of product characteristics.
200000023271 Declaration that stability studies will be conducted in accordance with the relevant guidelines for products where stability parameters could be affected. Data to be reported only if outside specifications (with proposed action).
200000023272 Results of appropriate real time stability studies (covering the entire shelf life) conducted in accordance with the relevant stability guidelines on at least two pilot scale batches of the finished product in the authorised packaging material and/or after first opening or reconstitution, as appropriate; where applicable, results of appropriate microbiological testing should be included.
200000023273 Copy of approved end of shelf life finished product specification and where applicable, specifications after dilution/reconstitution or first opening.
200000023274 Results from product and process development studies (including risk assessment and multivariate studies, as appropriate) demonstrating that a systematic mechanistic understanding of material attributes and process parameters to the critical quality attributes of the finished product has been achieved.
200000023275 Change management protocol related to the finished product.
200000023276 Declaration that any change should be within the range of currently approved limits. In addition, declaration that an assessment of comparability is not required for biological/immunological medicinal products.
200000023277 Copy of approved specifications of the finished product.
200000023278 Copy of the current (updated) Ph. Eur. Certificate of Suitability.
200000023279 In case of an addition of a manufacturing site, the variation application form should clearly outline the “present” and “proposed” manufacturers as listed in the application form.
200000023280 Where applicable, a document providing information of any materials falling within the scope of the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products including those which are used in the manufacture of the active substance/excipient. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023281 Where applicable, for active substance, a declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders listed in the application where the active substance is used as a starting material and a declaration by the QP of each of the manufacturing authorisation holders listed in the application as responsible for batch release. (SEE FULL DESCRIPTION IN GUIDELINE)
200000023282 Suitable evidence to confirm compliance of the water used in the final steps of the synthesis of the active substance with the corresponding requirements on quality of water for pharmaceutical use.
200000023283 Description, detailed drawing and composition of the device material and supplier where appropriate.
200000023284 Data to demonstrate accuracy, precision and compatibility of the device.
200000023285 Samples of the new device where applicable.
200000023286 Details of any new analytical method and summary of validation data.
200000023287 Batch analysis data on two production batches for all tests in the new specification.
200000023288 Declaration that the VAMF Certificate and Evaluation Report are fully applicable for the authorised product, VAMF holder has submitted the VAMF Certificate, Evaluation report and VAMF dossier to the MAH (where the MAH is different to the VAMF holder), the VAMF Certificate and Evaluation Report replace the previous VAMF documentation for this Marketing Authorisation.
200000023289 VAMF Certificate and Evaluation Report.
200000023290 An expert statement outlining all the changes introduced with the certified VAMF and evaluating their potential impact on the finished products including product specific risk assessments.
200000023291 The variation application form should clearly outline the “present” and “proposed” VAMF EMA Certificate (code number) in the MA dossier. When applicable, the variation application form should clearly list also all the other VAMFs to which the medicinal product refers even if they are not the subject of the application.
200000023292 Attached to the cover letter of the variation application: a reference to the Commission Decision concerned with the annexed Summary of Product Characteristics, Labelling or Package Leaflet.
200000023293 A declaration that the proposed Summary of Product Characteristics, Labelling and Package Leaflet is identical for the concerned sections to that annexed to the Commission Decision.
200000023294 Attached to the cover letter of the variation application: a reference to the agreement/assessment of the competent authority.
200000023295 Attached to the cover letter of the variation application: a reference to the procedure where the wording for one of the active substances was approved.
200000023296 Attached to the cover letter of the variation application: proof of authorisation of the legal status change (e.g. reference to the Commission Decision concerned)
200000023297 Justification for the deletion of the target species
90000005508 Annex 5.8 - Flow Chart
90000005513 Attachment 5.13
90000005519 Annex 5.19 - Starting Materials
90000005522 Annex 5.22 - Starting Materials
90000005523 Attachment 5.23