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Public Assessment Report

Decentralised Procedure

Linezolid 2 mg/ml solution for infusion Linezolid 600mg film coated tablets

Linezolid 100mg/5ml granules for oral suspension

Procedure No: UK/H/5156/001-3/DC

UK Licence No: PL 00057/1418-20

Pfizer Limited

PAR Linezolid granules, film-coated tablets and solution for infusion UK/H/5156/001-3/DC

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LAY SUMMARY

Linezolid 2 mg/ml solution for infusion

Linezolid 600mg film coated tablets Linezolid 100mg/5ml granules for oral suspension

(Linezolid, 2 mg/ml solution for infusion, 600mg film coated tablets or 100mg/5ml granules

for oral suspension)

This is a summary of the Public Assessment Report (PAR) for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/1418-20; UK/H/5156/001-3/DC). It explains how Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets. For practical information about using Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets patients should read the package leaflet or contact their doctor or pharmacist. What are these medicines and what are they used for? Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets are used to treat pneumonia and some infections in the skin or under the skin. These medicines are the same as Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61), which are already authorised. The company (Pharmacia Limited) that makes Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61) has agreed that its scientific data can be used as a basis for the grant of identical licences for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (informed consent). How do these medicines work? These medicines contain the active ingredient linezolid, which is an antibiotic of the oxazolidinones group that works by stopping the growth of certain bacteria (germs) that cause infections. How are these medicines used? Linezolid 100mg/5ml Granules for Oral Suspension come as granules, which will be made up exclusively by a healthcare professional; they will make a suspension for the patient to take. For adults the usual dose of this suspension is six 5 ml spoonfuls (600 mg linezolid), twice daily (every 12 hours). Before use, the bottle should be turned upside down a few times, but not shaken. Linezolid 2 mg/ml Solution for infusion will be given to the patient as an infusion into a vein by a drip, which will be given by a doctor or healthcare professional. For adults the usual dose is 300 ml (600 mg linezolid) given twice daily, over a period of 30 to 120 minutes.


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Linezolid 600 mg tablets should be swallowed whole with some water. For adults, the usual dose is one tablet (600 mg linezolid) twice daily (every twelve hours). If the patient is on kidney dialysis, they should take linezolid after their dialysis. A course of treatment for each of the three medicines listed above usually lasts 10 to 14 days but can last up to 28 days. The patient’s doctor will decide how long they should be treated. The patient’s doctor should perform regular blood tests to monitor their blood count. The patient’s doctor should monitor the patient’s eyesight if they are taking it for more than 28 days. Linezolid is not usually used in children and adolescents under 18 years old. Please read Section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration and the duration of treatment. These medicines can only be obtained with a prescription. Please refer to Section 3 of the package leaflets for information on how to use Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets. For further information on how these medicines are used, refer to the package leaflets and Summaries of Product Characteristics available on the Medicines and Healthcare products Regulatory Agency (MHRA) website. What benefits of these medicines have been shown in studies? Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets are considered identical to previously authorised Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61), with the same benefits and risks. So no new studies have been provided for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets but reference is made to the studies for Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61). What are the possible side effects from these medicines? Like all medicines, this medicine can cause side effects, although not everybody gets them. Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets are considered to be identical to the previously authorised applications for Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61) with the same benefits and risks. For a full list of all the side effects reported with Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets, see Section 4 of the package leaflet, available on the Medicines and Healthcare products Regulatory Agency (MHRA) website. For the full list of restrictions, see the package leaflet.


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Why are these medicines approved? It was decided that the benefits of Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets outweigh the identified risks and it was recommended that these products be approved for use. What measures are being taken to ensure the safe and effective use of these medicines? A Risk Management Plan has been developed to ensure that Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets are used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics and the package leaflets for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about these medicines Belgium, Finland Luxembourg and the UK agreed to grant marketing authorisations to Pfizer Limited for Linezolid 2 mg/ml infusion, Linezolid 600 mg tablets and Linezolid 100 mg/5 ml Granules for Oral Suspension on 24 October 2012. The marketing authorisations in the UK were granted on 23 November 2012. The full PAR for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets follows this summary. For more information about treatment with Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets read the package leaflets, or contact your doctor or pharmacist. This summary was last updated in April 2017.


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TABLE OF CONTENTS

I Introduction Page 6 II Quality aspects Page 7 III Non-clinical aspects Page 9 IV Clinical aspects Page 9 V Overall conclusion, benefit/risk assessment Page 9 and recommendation Table of content of the PAR update Page 19


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I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the member states considered that the applications for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/1418-20; UK/H/5156/001-3/DC) could be approved. These applications were submitted via the Decentralised Procedure, with the UK as Reference Member State (RMS), and Belgium, Finland and Luxembourg as Concerned Member States (CMS). These are prescription-only medicines indicated for the treatment of community-acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram-positive bacteria. It is also indicated for the treatment of complicated skin and soft tissue infections caused by Gram-positive bacteria. These are applications made under the Decentralised Procedure (DCP), according to Article 10c of Directive 2001/83/EC, as amended, abridged simple applications referring to Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61), which were originally granted to Pharmacia Limited on 5 January 2001. Linezolid selectively inhibits bacterial protein synthesis via a unique mechanism of action. Specifically, it binds to a site on the bacterial ribosome (23S of the 50S subunit) and prevents the formation of a functional 70S initiation complex, which is an essential component of the translation process. The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for these product types at all sites responsible for the manufacture, assembly and batch release of these products. The RMS and CMS considered that the application could be approved with the end of procedure (Day 210) on 24 October 2012. After a subsequent national phase, the licence was granted in the UK on 23 November 2012.


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II QUALITY ASPECTS II.1 Introduction These are simple, piggyback applications for Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/1418-20; UK/H/5156/001-3/DC) submitted under Article 10c (formerly Article 10.1(a)(i)) of Directive 2001/83/EC. The proposed MA holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom. The applications cross-refer to Zyvox 100mg/5ml Granules for Oral Solution, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00032/0259-61), which were originally granted to Pharmacia Limited on 5 January 2001. The current applications are considered valid. II.2. Drug Substance Drug substance specifications The proposed drug substance specifications are consistent with the details registered for the cross-reference products. II.3. Medicinal Product Name The proposed name of the products is Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets. The products have been named in-line with current requirements. Strength, pharmaceutical form, route of administration, container and pack sizes Linezolid 2mg/ml Solution for Infusion (PL 00057/1418): The 300ml solution is packed in a latex-free polyolefine film infusion bag sealed inside a foil laminate overwrap and packed in a box. Each box contains 1, 2, 3, 5, 6, 10, 20 or 25 infusion bags. The shelf-life (3 years) and storage conditions (before opening: Store in the original package (overwrap and carton) until ready to use; after opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user) are consistent with the details registered for the cross-reference product. Linezolid 600mg Film-Coated Tablets (PL 00057/1419):

• 10, 14, 20, 24, 30, 50, 60 or 100 tablets, packaged in white high-density polyethylene bottles, with polypropylene screw caps.

• Polyvinylchloride/aluminium blisters containing 10, 20, 30, 50, 60 and 100 tablets.

The proposed shelf-life (3 years) and storage conditions (none) are consistent with the details registered for the cross-reference product. Linezolid 100mg/5ml Granules for Oral Suspension (PL 00057/1420): 66g of granules for oral suspension in an amber Type III glass bottles (240ml), with polypropylene, child-resistant screw cap and a 2.5ml/5ml measuring spoon. The bottles are packed into boxes in pack sizes of 1, 5 or 10 bottles.


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The proposed shelf-life (2 years before reconstitution and 3 weeks after reconstitution) and storage conditions (“Keep the container tightly closed” before reconstitution and “Keep container in outer carton” after reconstitution) are consistent with the details registered for the cross-reference product. Legal status On approval, the products will be available as prescription-only medicines (legal status POM). Marketing authorisation holder/Contact Persons/Company Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.

The QP responsible for pharmacovigilance is stated and his CV is included. Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. Qualitative and quantitative compositions The proposed compositions are consistent with the details registered for the cross-reference products. Manufacturing processes The proposed manufacturing processes are consistent with the details registered for the cross-reference products and the maximum batch sizes are stated. Finished product/shelf-life specifications The proposed finished product specifications are in line with the details registered for the cross-reference products. TSE Compliance No materials of animal or human origin are included in these products. This is consistent with the cross-reference products. Expert Reports The applicant has included detailed expert reports in Module 2 of the applications. Signed declarations and copies of the experts’ CVs are enclosed in Module 1.4 for the quality, non-clinical and clinical experts. All are considered to have sufficient experience for their responsibilities. Product Names and Appearance See Section II.3 ‘Medicinal Product; Name’ for details of the proposed product name. The appearance of the product is identical to that of the cross-reference product. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The proposed SmPCs are consistent with the details registered for the cross-reference products. PATIENT INFORMATION LEAFLET (PIL)/CARTON PIL


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The PIL has been prepared in-line with the details registered for the cross-reference products.

The proposed artwork is comparable to the artwork registered for the cross-reference products and complies with statutory requirements. In-line with current legislation, the applicant has also included the name of the product in Braille on the outer packaging and has included sufficient space for a standard UK pharmacy dispensing label.

Carton and blister

II.4 Discussion on chemical, pharmaceutical and biological aspects The data submitted with these applications are acceptable. From a quality perspective, Marketing Authorisations should be granted. III NON-CLINICAL ASPECTS No new non-clinical data have been supplied with these applications and none are required for applications of this type. Ecotoxicity/environmental risk assessment (ERA) Suitable justification has been provided for non-submission of an Environmental Risk Assessment. As the applications are identical versions of already authorised products, it is not expected that environmental exposure will increase following approval of the Marketing Authorisations for the proposed products. Discussion on the non-clinical aspects The grant of Marketing Authorisations is recommended. IV CLINICAL ASPECTS No new clinical data have been supplied with these applications and none are required for applications of this type. Pharmacovigilance System and Risk Management Plan (RMP) The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. A suitable Risk Management Plan (RMP) has been provided. Discussion on the clinical aspects The grant of Marketing Authorisations is recommended. V Overall conclusion, benefit/risk assessment and recommendation QUALITY Linezolid 100mg/5ml Granules for Oral Suspension, 2mg/ml Solution for Infusion and 600mg Film-Coated Tablets (PL 00057/1418-20; UK/H/5156/001-3/DC) are identical to the already licensed reference products. The products are, therefore, pharmaceutically satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type.


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CLINICAL PHARMACOLOGY/EFFICACY No new clinical pharmacology/efficacy data have been submitted with these applications and none are required for applications of this type. SAFETY No new safety data have been submitted with these applications and none are required for applications of this type. No new or unexpected safety concerns arise from these applications. The SmPCs, PIL and labelling are satisfactory. BENEFIT/RISK ASSESSMENT The quality of the products is acceptable and no new non-clinical or clinical safety concerns have been identified. Extensive clinical experience with linezolid is considered to have demonstrated the therapeutic value of the compound. The benefit/risk is, therefore, considered to be positive.


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Summaries of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and Labels The SmPCs and PILs are consistent with the details registered for the cross-reference products. In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. The current approved labelling for Linezolid 2 mg/ml Solution for Infusion (PL 00057/1418) is presented in Annex 2 of this report. The current approved labelling for Linezolid 100 mg/5 ml granules for oral suspension (PL 00057/1419) is presented below:


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The current approved labelling text for Linezolid 600 mg film-coated tablets (PL 00057/1420) is presented below:


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Table of content of the PAR update

Steps taken after the initial procedure with an influence on the Public Assessment Report (Type II variations, PSURs, commitments)

Date submitted

Application type

Description Outcome

06/12/2012 VAR Medical Type II

To update section 4.6 (pregnancy and lactation) of the SmPC following the Post Marketing Commitment after Day 160 end of procedure. As a consequence, the PIL has been updated.

Variation granted 23/09/2013

24/03/2016 Medical Type 1B

PL 00057/1418-0019: To update sections 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.4, 6.6 of the SmPC in line with the QRD template. Consequently the leaflet and labelling have been updated.

Approved on 21/03/2017

24/03/2016 Medical Type 1B

PL 00057/1420-0019: To update sections 1, 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.6 of the SmPC in line with the QRD. Consequently the leaflet has been updated.

Approved on 21/03/2017


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ANNEX 1 – CLINICAL VARIATION ASSESSMENT REPORT

RECOMMENDATION Based on the review of the data provided, the Reference Member State (RMS) considers that the variation application is approvable.

EXECUTIVE SUMMARY

Scope of the variation This variation seeks approval for modifications to the Summary of Product Characteristics (SmPC) and Patient information leaflet (PIL) for the following products: Linezolid 2 mg/mL solution for infusion Linezolid 100 mg/5 mL granules for oral suspension Linezolid 600 mg film-coated tablets The proposed changes satisfy the post-marketing commitment made during procedures UK/H/5156/01-03/DC, whereby QRD standard headings and wording relating to Section 4.6 of the SmPC and Section 2 of the PIL have been added. In addition, standard headings have been modified in sections 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.5 and 6.6 of the SmPCs for the Film-coated tablets and Granules for Oral Suspension.

SCIENFIC DISCUSSION

Product information

Summary of Product Characteristics During the course of the decentralised procedures UK/H/5156/01-03/DC, the Marketing Authorisation Holder (MAH) committed to revising Section 4.6 of the SmPC to include the relevant conclusions from fertility studies. The applicant has proposed the following text for Section 4.6 of the SmPC for the three products containing Linezolid. 4.6 Fertility, pregnancy and lactation

There are no adequate data from the use of linezolid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). A potential risk for humans exists.

Pregnancy

Linezolid should not be used during pregnancy unless clearly necessary i.e. only if the potential benefit outweighs the theoretical risk.

Animal data suggest that linezolid and its metabolites may pass into breast milk and, accordingly, breast-feeding should be discontinued prior to and throughout administration.

Breast-feeding


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In animal studies, linezolid caused a reduction in fertility (see section 5.3). Fertility

The standard headings have also been modified in sections 4.2, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.5 and 6.6 of the SmPCs for the Film-coated tablets and Granules for Oral Suspension, which is acceptable.

Package leaflet Revisions have been made to the pregnancy, breast-feeding and fertility subsection within Section 2 of the PIL. However, minor amendments were requested as outlined in tracked changes below: Pregnancy, breast-feeding and fertility The effect of Linezolid in pregnant women is not known. Therefore, it should not be taken in pregnancy unless advised by your doctor. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not breast-feed when taking Linezolid because it passes into breast milk and could affect the baby.

SUMMARY Amendments to the SmPC and PIL for Linezolid 2 mg/mL solution for infusion, Linezolid 100 mg/5 mL granules for oral suspension and Linezolid 600 mg film-coated tablets have been proposed by the MAH. These changes were made in order to satisfy a post-approval commitment concerning the decentralised procedures UK/H/5156/01-03/DC. Further amendments to Section 4.6 of the SmPC and the pregnancy, breast-feeding and fertility subsection of the PIL were requested (as outlined in Section II of this report) prior to the approval of this variation.

ASSESSMENT OF THE RESPONSES The applicant has provided the responses and the changes to the SmPC and the PIL have been made as proposed. Hence Section 4.6 of the SmPC now been amended as follows:

4.6 Fertility, pregnancy and lactation

There are no adequate data from the use of linezolid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). A potential risk for humans exists.

Pregnancy

Linezolid should not be used during pregnancy unless clearly necessary i.e. only if the potential benefit outweighs the theoretical risk.

Animal data suggest that linezolid and its metabolites may pass into breast milk and, accordingly, breastfeeding should be discontinued prior to and throughout administration.

Breast-feeding


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In animal studies, linezolid caused a reduction in fertility (see section 5.3). Fertility

The corresponding section of the PIL has been amended as follows: Pregnancy, breast-feeding, and fertility The effect of Linezolid in pregnant women is not known. Therefore it should not be taken in pregnancy unless advised by your doctor. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not breast-feed when taking Linezolid because it passes into breast milk and could affect the baby.

OVERALL CONCLUSION The variation was approved on 23rd September 2013 and the updated SmPCs fragment and the PILs have been incorporated into these Marketing Authorisations. The proposed changes are acceptable. The current approved UK version of the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for these products are available on the MHRA website.


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ANNEX 2 Our Reference: PL 00057/1418-0019 Product: Linezolid Pfizer 600 mg film-coated tablets Marketing Authorisation Holder: Pfizer Ltd Active Ingredient(s): Linezolid Type of Procedure: Mutual Recognition Submission Type: Variation Submission Category: Type IB Submission Complexity: Standard EU Procedure Number (if applicable): UK/H/5156/001/IB/026 Reason: To update sections 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.4, 6.6 of the SmPC in line with the QRD template. Consequently the leaflet and labelling have been updated. Supporting Evidence Revised SmPC fragments, PIL and labelling. Evaluation The proposed changes to the SmPC, PIL and labelling are in line with the QRD template. The updated SmPC fragments, PIL and labelling have been incorporated into the Marketing Authorisation. Conclusion The proposed changes to the SmPCs, PIL and labelling are acceptable. In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPC and package leaflet for this product is available on the MHRA website. The approved labelling text for the variation is included below:


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Decision - Approved on 21 March 2017.


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ANNEX 3 Our Reference: PL 00057/1420-0019 Product: Linezolid 100 mg/5 ml granules for oral suspension Marketing Authorisation Holder: Pfizer Ltd Active Ingredient(s): Linezolid Type of Procedure: Mutual Recognition Submission Type: Variation Submission Category: Type IB Submission Complexity: Standard EU Procedure Number (if applicable): UK/H/5156/003/IB/028 Reason: To update sections 1, 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.4, 6.6 of the SmPC in line with the QRD template. Consequently the leaflet has been updated. Supporting Evidence Revised SmPC fragments and PIL. Evaluation The proposed changes to the SmPC and PIL are in line with the QRD template. The updated SmPC fragments and PIL have been incorporated into the Marketing Authorisation. Conclusion The proposed changes to the SmPC and PIL are acceptable. In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPC and package leaflet for this product is available on the MHRA website. Decision - Approved on 21 March 2017.

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