Traumeel Ointment NR 08927/0019 UKPAR - GOV.UK · mhra par; traumeel ointment, nr 08927/0019...

1 MHRA PAR; TRAUMEEL OINTMENT, NR 08927/0019

Traumeel Ointment

NR 08927/0019

UKPAR

TABLE OF CONTENTS

Lay summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 27

Summary of Product Characteristics

Page 28

Product Information Leaflet

Page 29

Labelling Page 30


TRAUMEEL OINTMENT

NR 08927/0019

LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Biologische Heilmittel Heel GmbH a Homeopathic Marketing Authorisation for the homeopathic medicinal product Traumeel Ointment (Homeopathic Marketing Authorisation number: NR 08927/0019) on 13 June 2014. This product is available without prescription and can be bought from pharmacies. Traumeel Ointment is a homeopathic medicinal product used within the homeopathic tradition to relieve symptoms such as pain and swelling which may result from minor injuries such as sprains, muscular strains and bruising. These indications are based on published Materia medica references and other bibliographic evidence. The active ingredients in Traumeel Ointment are Achillea millefolium 3X, Aconitum napellus 4X, Atropa belladonna 4X, Hepar sulfuris 9X, Matricaria recutita 2X, Mercurius solubilis Hahnemanni 9X, Symphytum officinale 7X, Bellis perennis 3X, Calendula officinalis 2X, Echinacea angustifolia 2X or Echinacea pallida 2X (or a mixture of both species), Echinacea purpurea 2X, Hamamelis virginiana 2X, Hypericum perforatum 9X and Arnica montana 4X. No new or unexpected safety concerns arose from this application and it was, therefore, decided that a Homeopathic Marketing Authorisation could be granted.


TRAUMEEL OINTMENT

NR 08927/0019

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical Assessment

Page 5

Non-clinical and clinical safety assessment

Page 23

Clinical assessment (non safety)

Page 24

Overall conclusion and risk assessment Page 26


INTRODUCTION

The MHRA granted a Homeopathic Marketing Authorisation for the homeopathic medicinal product Traumeel Ointment on 13 June 2014. This product has Pharmacy status. The application was submitted in accordance with Article 16.2 of Directive 2001/83/EC, as amended, under the National Rules Authorisation Scheme. Traumeel Ointment contains the homeopathic stocks Achillea millefolium 3X, Aconitum napellus 4X, Atropa belladonna 4X, Hepar sulfuris 9X, Matricaria recutita 2X, Mercurius solubilis Hahnemanni 9X, Symphytum officinale 7X, Bellis perennis 3X, Calendula officinalis 2X, Echinacea angustifolia 2X or Echinacea pallida 2X (or a mixture of both species), Echinacea purpurea 2X, Hamamelis virginiana 2X, Hypericum perforatum 9X and Arnica montana 4X and is used to relieve symptoms such as pain and swelling which may result from minor injuries such as sprains, muscular strains and bruising. Achillea millefolium, Aconitum napellus, Atropa belladonna, Hepar sulfuris, Matricaria recutita, Mercurius solubilis Hahnemanni, Symphytum officinale, Bellis perennis, Calendula officinalis, Echinacea angustifolia, Echinacea pallida, Echinacea purpurea, Hamamelis virginiana, Hypericum perforatum and Arnica montana are established homeopathic remedies and their traditional use in homeopathy is well documented. In support of this application to authorise Traumeel Ointment published Materia medica references and other bibliographic evidence has been provided.


PHARMACEUTICAL ASSESSMENT

HERBAL SUBSTANCE: ACHILLEA MILLEFOLIUM

Scientific/Latin name: Achillea millefolium L. Plant family: Asteraceae Manufacture The fresh aerial parts of Achillea millefolium are hand collected from the wild in Europe during flowering time. The plant was delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of growth promoters, pesticides or herbicides. The fertiliser ammonia nitrate is used and its use has been justified. Control of the Herbal Substance

The Achillea millefolium is described in the German Homeopathic Pharmacopoeia (GHP) and its quality is satisfactorily controlled.

Container Closure System No details are required.

Stability A shelf-life for the herbal substance is not necessary because it is collected and used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): ACHILLEA MILLEFOLIUM MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: An olive green to brownish liquid Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.

Control of Homeopathic Stock

A satisfactory specification with appropriate tests and limits has been provided for the homeopathic stock. Appropriate analytical procedures are used to control the quality of the homeopathic stock. As the analytical methods are in accordance with the GHP monograph


additional validation is not required. All non-compendial methods used to test the stock have been suitably validated.

Certificates of Analysis have been provided for batches of the homeopathic stock, demonstrating satisfactory compliance with the proposed specifications. Container Closure System Satisfactory details of the container closure system are provided.

Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock.

HERBAL SUBSTANCE: ACONITUM NAPELLUS Scientific/Latin name: Aconitum napellus L. Plant family: Ranunculaceae Manufacture The Aconitum napellus plants are cultivated and sourced from Europe. The plants are harvested by hand during the blooming period. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without use of pesticides, herbicides or growth promoters. The fertiliser, ammonia nitrate is used and its use has been justified. Control of the Herbal Substance

The Aconitum napellus is described in the GHP and its quality is satisfactorily controlled.

Container Closure System No details are needed.

Stability A shelf-life for the herbal substance is not necessary because it is collected and used in the fresh state. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): ACONITUM NAPELLUS MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A greenish yellow, later turning brownish

yellow, liquid with a characteristic odour Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.3 of the


Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.


A satisfactory specification with appropriate tests and limits has been provided for the homeopathic stock. Appropriate analytical procedures are used to control the quality of the homeopathic stock. As the analytical methods are in accordance with the GHP monograph additional validation is not required. All non-compendial methods used to test the stock have been suitably validated.



HERBAL SUBSTANCE: ARNICA MONTANA Scientific/Latin name: Arnica montana L. Plant family: Asteraceae Manufacture The Arnica montana plants are cultivated in Germany. The plants dried underground parts of the plants are harvested by hand and machine after vegetation. The herbal substance is then dried. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of fertilisers, pesticides, herbicides and growth accelerators. Control of the Herbal Substance

The Arnica montana is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture.


ACTIVE INGREDIENT (HOMEOPATHIC STOCK): ARNICA MONTANA MOTHER TINCTURE Extraction solvent: Ethanol 50% w/w General properties: A yellow liquid with a sharp, characteristic

odour and a spicy, aromatic, slightly burning taste

Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.8 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.





HERBAL SUBSTANCE: ATROPA BELLADONNA Scientific/Latin name: Atropa belladonna L. Plant family: Solanaceae Manufacture The Atropa belladonna plants are collected from the wild in Europe. The plants are collected by hand at the end of flowering time. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of fertilisers, pesticides, herbicides and growth accelerators. Control of the Herbal Substance


The Atropa belladonna is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): ATROPA BELLADONNA MOTHER

TINCTURE Extraction solvent: Ethanol 86 % General properties: A brown liquid with a characteristic odour Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.3 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.




Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCE: BELLIS PERENNIS Scientific/Latin name: Bellis perennis L. Plant family: Asteraceae Manufacture


The Bellis perennis plants are cultivated and sourced from Europe. The plants are harvested by hand at during the blooming period. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of fertilisers, pesticides, herbicides and growth accelerators. Control of the Herbal Substance

The Bellis perennis is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used fresh and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): BELLIS PERENNIS MOTHER TINCTURE Extraction solvent: Ethanol 86 % General properties: A yellowish green to yellowish brown liquid

with a pleasant odour Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.3 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.





Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCE: CALENDULA OFFICINALIS Scientific/Latin name: Calendula officinalis L. Plant family: Asteraceae Manufacture The Calendula officinalis plants are cultivated and sourced from Europe. The plants are harvested by hand at flowering time. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of pesticides, herbicides and growth accelerators. The fertilizers potassium sulphate, superphospahte enriched and nitrochalk are used. Control of the Herbal Substance

The Calendula officinalis is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): CALENDULA OFFICINALIS MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A yellowish green to brownish green liquid with

a slightly aromatic odour and a mildly spicy taste Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.


A satisfactory specification with appropriate tests and limits has been provided for the homeopathic stock.


Appropriate analytical procedures are used to control the quality of the homeopathic stock. As the analytical methods are in accordance with the GHP monograph additional validation is not required. All non-compendial methods used to test the stock have been suitably validated.


Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCES: ECHINACEA ANGUSTIFOLIA AND/OR

ECHINACEA PALLIDA Scientific/Latin name: Echinacea angustifolia (DC.) and Echinacea

pallida (Nutt.) Plant family: Asteraceae Manufacture The Echinacea angustifolia/pallida plants are cultivated and sourced from Europe. The plants are harvested by hand at flowering time. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of pesticides, herbicides and growth accelerators. The fertilizers ammonia nitrate, superphospahte enriched and potassium sulphate are used. Control of the Herbal Substance

The Echinacea angustifolia/pallida is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used in the fresh state. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): ECHINACEA ANGUSTIFOLIA/PALLIDA

MOTHER TINCTURE Extraction solvent: Ethanol 86 % (m/m)


General properties: A yellowish green liquid with an aromatic odour and a sweetish taste

Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.




Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCE: ECHINACEA PURPUREA Scientific/Latin name: Echinacea purpurea L. Plant family: Asteraceae Manufacture The Echinacea purpurea plants are cultivated and sourced from Europe. The fresh aerial parts of the plants are harvested by hand at flowering time. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of pesticides, herbicides and growth accelerators. The fertilizers ammonia nitrate is used. Control of the Herbal Substance

The Echinacea purpurea is described in the GHP and its quality is satisfactorily controlled.



Stability

A shelf-life for the herbal substance is not necessary because it is used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): ECHINACEA PURPUREA MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A yellowish green liquid with an aromatic odour

and a sweetish taste Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.




Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCE: HAMAMELIS VIRGINIANA Scientific/Latin name: Hamamelis virginiana L. Plant family: Hamamelidaceae Manufacture The Hamamelis virginiana trees are cultivated in Poland. Fresh bark from the roots or branches of the trees, or a mixture thereof, is harvested in autumn. The plant material is then delivered for processing within 24 hours of collection.


The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of pesticides, herbicides and growth accelerators. The fertilizers potassium sulphate, superphosphate enriched and ammonia nitrate are used. Control of the Herbal Substance

The Hamamelis virginiana is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): HAMAMELIS VIRGINIANA MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A reddish brown liquid with an astringent taste Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.






RAW MATERIAL/SUBSTANCE: HEPAR SULFURIS CALCAREUM Manufacture The substance is obtained by calcining a mixture of calcium carbonicum Hahnemanni and sulfur as sulfide. Control of the Substance

The Hepar sulfuris calcareum is described in the GHP and its quality is satisfactorily controlled.


Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): HEPAR SULFURIS TRITURATION Diluent: Lactose monohydrate Ph. Eur. General properties: A white to grey-white powder with an odour of

hydrogen sulfide Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 4.1.1 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the lactose used in the manufacture of the homeopathic stock have been provided.


A satisfactory specification with appropriate tests and limits has been provided for the homeopathic stock. Appropriate analytical procedures are used to control the quality of the homeopathic stock. As the analytical methods are in accordance with the Ph. Eur. or GHP monograph additional validation is not required.




HERBAL SUBSTANCE: HYPERICUM PERFORATUM Scientific/Latin name: Hypericum perforatum L. Plant family: Hypericaceae Manufacture The Hypericum perforatum plants are cultivated and sourced from Europe. The whole fresh plants are collected at the beginning of flowering time. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of pesticides, herbicides and growth accelerators. The fertilizers agricultural limestone, potassium sulphate, ammonia nitrate are used and their use has been fully justified. Control of the Herbal Substance

The Hypericum perforatum is described in the Ph. Eur. and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used in the fresh state and is tested according to the monograph for the herbal drug in the Ph. Eur. immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): HYPERICUM PERFORATUM MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A dark red to brownish red liquid Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.





Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCE: MATRICARIA RECUTITA Scientific/Latin name: Matricaria recutita L. Plant family: Asteraceae Manufacture The Matricaria recutita plants are cultivated in Poland. The whole fresh plant is harvested by hand during flowering. The plant material is then delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of pesticides, herbicides and growth accelerators. The fertilizer ammonia nitrate is used and its use has been justified. Control of the Herbal Substance

The Matricaria recutita is described in the GHP and its quality is satisfactorily controlled.


Stability A shelf-life for the herbal substance is not necessary because it is used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): MATRICARIA RECUTITA MOTHER

TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A golden-yellow to yellowish green liquid with

a characteristic aromatic odour Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for


the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.




Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. RAW MATERIAL/SUBSTANCE: MERCURIUS SOLUBILIS HAHNEMANNI Manufacture The substance is obtained by mixing mercury (II) amidonitrate and metallic mercury. Control of the Substance

The Mercurius solubilis hahnemanni is described in the GHP and its quality is satisfactorily controlled.


Stability Stability studies have been carried out and the results support the proposed shelf life. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): MERCURIUS SOLUBILIS HAHNEMANNI

TRITURATION Diluent: Lactose monohydrate Ph. Eur. General properties: The 1st decimal trituration is a grey powder Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 4.4.1 of the


Ph. Eur. The in-process controls are satisfactorily detailed. A Certificate of Analysis for the lactose used in the manufacture of the homeopathic stock have been provided.




Stability Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HERBAL SUBSTANCE: SYMPHYTUM OFFICINALE Scientific/Latin name: Symphytum officinale L. Plant family: Boraginaceae Manufacture The fresh underground parts of Symphytum officinale are hand collected from the wild in Europe prior to flowering. The plant was delivered for processing within 24 hours of collection. The herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) without the use of growth promoters, pesticides or herbicides. Control of the Herbal Substance

The Symphytum officinale is described in the German Homeopathic Pharmacopoeia (GHP) and its quality is satisfactorily controlled.

Container Closure System No details are required.

Stability A shelf-life for the herbal substance is not necessary because it is collected and used in the fresh state and is tested according to the monograph for the herbal drug in the GHP immediately prior to tincture manufacture.


ACTIVE INGREDIENT (HOMEOPATHIC STOCK): SYMPHYTUM OFFICINALE TINCTURE Extraction solvent: Ethanol 86 % (m/m) General properties: A reddish brown to dark brown liquid with a

characteristic odour Manufacture A satisfactory description of the manufacturing process of the homeopathic stock has been provided. The homeopathic stock is prepared according to method 1.1.5 of the Ph. Eur. The in-process controls are satisfactorily detailed. Certificates of Analysis for the ethanol and purified water used in the manufacture of the homeopathic stock have been provided.




Stability Stability testing was not performed on the homeopathic stock Symphytum officinale mother tincture. This is acceptable as the mother tincture is tested for compliance with the specification prior to use in manufacture on each occasion.

HOMEOPATHIC MEDICINAL PRODUCT: TRAUMEEL OINTMENT

Description and Composition of the Homeopathic Product The finished product is a white to red-white ointment containing Achillea millefolium 3X, Aconitum napellus 4X, Atropa belladonna 4X, Hepar sulfuris 9X, Matricaria recutita 2X, Mercurius solubilis Hahnemanni 9X, Symphytum officinale 7X, Bellis perennis 3X, Calendula officinalis 2X, Echinacea angustifolia 2X or Echinacea pallida 2X (or a mixture of both species), Echinacea purpurea 2X, Hamamelis virginiana 2X, Hypericum perforatum 9X and Arnica montana 4X and the excipients liquid paraffin, cetostearyl alcohol (type A), white soft paraffin, water (purified) and ethanol (96%). Certificates of Analysis for the excipients used in the manufacture of the finished product have been provided. The excipients comply with their respective Ph. Eur. monographs and are considered to be compatible with the homeopathic stocks.


Manufacture A flow diagram outlining the various stages of the manufacturing process and the in-process controls is provided. The stocks present in the homeopathic medicinal product are prepared according to Ph. Eur. methods. Control of the Homeopathic Product The finished product specification is detailed and the tests and limits used were found to be satisfactory for a product of this nature. All analytical test methods are described in the Ph. Eur. and therefore validation is not necessary. Certificates of Analysis have been presented for batches of the homeopathic medicinal product, demonstrating little inter-batch variation.

Container Closure System The product is presented in aluminium tubes with a protective lacquer in-and outside closed with a screw cap, in a cardboard box. Pack sizes of 25, 50 or 100 g ointment have been authorised, although not all pack sizes may be marketed. The components of the primary packaging system comply with current legislation relating to materials and articles intended to come into contact with foodstuffs.

Stability Stability studies were conducted under ICH conditions on product batches in the

container type proposed for marketing. This product has a shelf life of 3 years when stored in an unopened container, reduced to 12 months once the container is first opened. This is appropriate when the product is stored in the original container. Summary of Product Characteristics, Labels and Patient Information Leaflet The product literature for this product is pharmaceutically satisfactory. A package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. CONCLUSION There are no objections to the granting of a Homeopathic Marketing Authorisation from a quality point of view.


NON-CLINICAL AND CLINICAL SAFETY ASSESSMENT The safety data which must be submitted by the Applicant is set out in Schedule 1A – Part 1 and Part 2 of Statutory Instrument 2006 No.1952 The Medicines for Human Use [National Rules for Homeopathic Products) Regulations 2006. The Applicant has presented an overview of the safety of the fourteen homeopathic stocks in the finished product and considers that the toxicological profiles of the homeopathic stocks are sufficiently described. In order to evaluate the safety of the homeopathic stocks in the finished product, the concentration of mother tincture or starting material daily dose has been determined. The Applicant concluded that the concentration of mother tincture or starting material in the finished product is such that the risk of adverse effects with the daily recommended dose is low and that the dilution of stocks in the finished product is consistent with that recommended in the Commission D monographs. The Applicant concluded that given the toxicological profiles of the individual stocks and their concentration in the finished product, the information is sufficient to demonstrate that the risk of any toxic effects is low. Regarding the combination of stocks in the finished product, long term clinical and post marketing experience in many countries indicates that Traumeel Ointment has an acceptable safety profile. It is considered that sufficient information and calculations have been submitted to demonstrate that the risk of adverse effects following administration of the usual recommended daily dose and the maximum daily dose is low. The excipients used in Traumeel Ointment are all of Ph. Eur. standard and do not pose any safety concerns. The pharmacovigilance system fulfils the requirements. The applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the collection and notification of any adverse reaction suspected of occurring in the Community or in a third country. Traumeel Ointment contains cetostearyl alcohol. Warnings have been included in the SmPC, patient information leaflet and labels accordingly. The Applicant concluded that Traumeel Ointment can be regarded as safe when used for the intended purpose and according to instructions. CONCLUSION There are no objections to the granting of a Homeopathic Marketing Authorisation from a safety point of view.


CLINICAL ASSESSMENT (NON SAFETY)

LEGAL STATUS One of the ingredients, Aconitum napellus, is classified as a prescription only medicine (POM) up to 6X dilution. However, an exemption from POM control for Aconitum napellus exists for external use and, consequently, Traumeel ointment is classified as a pharmacy only (P) product and will be available from a registered pharmacy without a medical practitioner’s prescription. INDICATION The applicant has proposed the following indication: “A homeopathic medicinal product used within the homeopathic tradition to relieve symptoms such as pain and swelling which may result from minor injuries such as sprains, muscular strains and bruising” This indication is acceptable. EVIDENCE SUPPORTING THE PROPOSED INDICATION Schedule 1A Parts 1 and 3 of SI 2006 No. 1952 The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 specifies the data that must be provided to support the use of the product in the indications sought. The Applicant must provide one or more of the following – published scientific literature, homeopathic provings, study reports in relation to the product which is the subject of the application. An evaluation of the data must be provided, including an explanation as to how the data establishes that the product to be authorised has a recognised level of use in the indications sought. The data provided must be sufficient to demonstrate that UK homeopathic practitioners would accept the usage of the product within the homeopathic tradition for the indications sought. Justification for homeopathic use of the stock The applicant has provided published Materia medica references and other bibliographic evidence to support the traditional homeopathic use of the individual stocks in the indications sought. Justification for the combination The applicant has provided published Materia medica references and other bibliographic evidence to support the combination of the stocks in the indications sought. Justification for the homeopathic potency The applicant has provided an acceptable statement to support the potencies of the stocks used. Justification to demonstrate use within the UK homeopathic tradition Statements from UK medical homeopathic practitioners supporting the use of the product within the indications sought have been provided. The statements are satisfactory.


CONCLUSION There are no objections to the granting of a Homeopathic Marketing Authorisation from a clinical point of view.


OVERALL CONCLUSION AND RISK ASSESSMENT

QUALITY The quality data submitted with this application are satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for an application of this type. HOMEOPATHIC USE AND SAFETY The applicant has provided published Materia medica references and other bibliographic evidence to fulfil the requirements for this type of application. These references relate to the indications sought and are, therefore, acceptable. The SmPC, PIL and labelling of the product are satisfactory. RISK ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified.


TRAUMEEL OINTMENT

NR 08927/0019

STEPS TAKEN FOR ASSESSMENT

1 The MHRA received an application under the Homeopathic National Rules Scheme (Article 16.2) on 22 June 2011

2 Following standard checks and communication with the applicant the MHRA considered the application valid on 7 November 2011

3 Following assessment of the application and a meeting of the Advisory Board on the Registration of Homeopathic products (ABRH) the MHRA requested further information relating to the dossier

4 The applicant responded to the MHRA’s request, providing further information on the dossier

5 Following assessment of the response further information was requested on 26 September 2012

6 The applicant responded to the MHRA’s request, providing further information on the dossier on 9 April 2014

7 A National Rules Marketing Authorisation was granted on 13 June 2014


SUMMARY OF PRODUCT CHARACTERISTICS

In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website.


PATIENT INFORMATION LEAFLET

In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website.


LABELLING

25 g pack label:

25 g pack carton:


50 g pack label:

50 g pack carton:


100 g pack label:

100 g pack carton:

Traumeel Ointment NR 08927/0019 UKPAR - GOV.UK · mhra par; traumeel ointment, nr 08927/0019...

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Transcript of Traumeel Ointment NR 08927/0019 UKPAR - GOV.UK · mhra par; traumeel ointment, nr 08927/0019...