Summary product characteristic, labelling, package leaflet

Summary products characteristic

• Template  for Summary product characteristic, labelling, package leaflet
• Template for labelling, package leaflet for homeopathic medicinal products
• Statements for use in Section 4.6 “Pregnancy and lactation” of SmPC
• MedDRA terminology to be used in section 4.8 „undesirable effects“ of SmPC
• Statements to be used in section 6.4 “Special precautions for storage“ of SmPC, labelling, package leaflet .

Common Baltic procedure

• Common Baltic Package Guidance 
• Common Baltic package procedure 
• Application form 

Common PL_LT procedure

• Flow chart 
• Recommendations  
• Procedure  
• Application form  

Useful links

• CMDh ANNOTATED QRD TEMPLATE FOR MR/DC PROCEDURES http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/QRD/CMDh_201_2005_Rev7_2013_04-Clean.pdf
• Composition of names of medicinal products (only in Lithuanian)
• Guideline on the acceptability of names for human medicinal products processed through the centralised procedure http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004142.pdf
• QRD RECOMMENDATIONS ON THE EXPRESSION OF STRENGTH IN THE NAME OF CENTRALLY AUTHORISED HUMAN MEDICINAL PRODUCTS (AS STATED IN SECTION 1 OF SPC, AND IN THE NAME SECTION OF LABELLING AND PL) http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500056428.pdf
• List of names for substances for pharmaceutical use and preparations presented in European Pharmacopoeia
• A Guideline of changing the classification for the supply of a medicinal product for human usehttp://ec.europa.eu/health/files/eudralex/vol-2/c/switchguide_160106_en.pdf
• Guidance concerning the Braile requirements for labelling and the package leaflet http://ec.europa.eu/health/files/pharmacos/docs/doc2005/04_05/braille_text20050411_en.pdf 
• Lists of Standard Terms for pharmaceutical Dosage forms, for Containers, closures and administration devices, for Combined terms and for Routes and methods of administration
• The list of International Non – Proprietary Names (INN) for pharmaceutical substances in English, Lithuanian and Latin languages.
• Composition of names of medicinal products (only in Lithuanian)
• List of names for substances for pharmaceutical use and preparations presented in European Pharmacopoeia
• A Guideline of changing the classification for the supply of a medicinal product for human use 
• Lists of Standard Terms for pharmaceutical Dosage forms, for Containers, closures and administration devices, for Combined terms and for Routes and methods of administration.
• The list of International Non – Proprietary Names (INN) for pharmaceutical substances in English, Lithuanian and Latin languages