CRED SMPC 2024

17/09/2024

Class labelling

How

Wording that is enforced across a class of compounds i.e. those sharing a common mechanism of action OR specific guidance for the indication

e.g. Methylphenidate – treatment for ADHD

● Article 31 referral - Elements recommended for inclusion in Summaries of Product Characteristics for methylphenidate-containing medicinal products authorised for the treatment of ADHD in children aged six years and above and adolescents. Wording recommended by the CHMP on 22 January 2009.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Attention-Deficit/Hyperactivity Disorder (ADHD)

Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptom.

• https://www.ema.europa.eu/en/medicines/human/referrals/methylphenidate

The Organisation for Professionals in Regulatory Affairs

• https://www.hma.eu/human-medicines/cmdh/product-information.html • https://www.ema.europa.eu/en/medicines/download-medicine-data

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See Further Resources section

How

• Scientific guidelines with SmPC recommendations - Clinical Efficacy and safety, Quality & biological, Non-Clinical • EMA training presentations on how to prepares a SmPC, ▪ Which Covers all sections of the SmPC, with additional topics such as generic/hybrid/biosimilar products, Shows some practical examples and FAQs ▪ Section also has guidelines for assessors • SmPC appendices such as - MEDRA terminology 4.8, P&L statements 4.6, storage conditions • Link to some of the key QRD and other EMA references documents ● QRD convention to be followed for the EMA-QRD templates [e.g. page set-up, margins, font size, bullet points] ● Compilation of QRD decisions on stylistic matters in product information e.g. overuse of invented name, number separators to use for the various languages ● Compilation of QRD decisions on the use of terms e.g. Adverse effects should not be used. Instead use adverse reactions or adverse events. ● Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ - Examples of excipient language • EDQM standard terms - includes standard terms & definition i.e. pharmaceutical dosage form, route and method of administration

The Organisation for Professionals in Regulatory Affairs

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