Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised
Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised
Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised
Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised
Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised
Barrymore has been struggling with perimenopause symptoms for more than a year now, and says this product has changed her life.
Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).
High treatment expenses, inadequate insurance, and lack of know-how may also prevent sufferers' capacity to get hold of better oncology treatments in China.
1
Questions & Answers on the European Union framework
for (traditional) herbal medicinal products, including those
from a ?non-European? tradition
Table of Content
1.
SAWP
Scientific Advice Working Party
SmPC
Summary of Product Characteristics
THMP
Traditional Herbal Medicinal Product
TUR
Traditional Use Registration
WEU
Well-Established Use
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 1
What are herbal substances, herbal preparations, and herbal medicinal products?
Question 5
Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
products (HMPs), including traditional herbal medicinal products (THMPs), in the European
Union (EU)?
Question 12
Which indications can be granted for traditional herbal medicinal products (THMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
29 February 2024
Compilation of QRD decisions on stylistic matters in product information
Issues
Abbreviations
Connected problems
Subscript and superscript
QRD Suggestions
Acronyms must be written in their standard form; e.g.
Not always understood,
Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.
Page 2/23
Issues
Connected problems
QRD Suggestions
emphasise in the labelling
the special handling prior
to administration of the
product.
Inconsistencies in style are
Once a particular style or house style has been selected, it must be used consistently throughout the text.
information annexes?
Page 3/23
Issues
Desiccant
Connected problems
QRD Suggestions
For medicinal products
The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains
packaged with a desiccant
the desiccant.
mistake the desiccant for a
is available space.
where can this be
SmPC and section 4 of the labelling.
Page 5/23
Issues
Foreign terms
Connected problems
QRD Suggestions
Foreign terms, particularly
Foreign terms must be written in italics; e.g.
physician is often referred
as ?she? when the medicinal product is exclusively for use by males or females.
measurements are
used by elderly patients), in brackets after the metric measures in the English text.
Page 6/23
Issues
Connected problems
QRD Suggestions
product name is composed
of MAH+INN?
Page 7/23
Issues
Connected problems
QRD Suggestions
MT: English
BG: Bulgarian
NL: Dutch
CZ: Czech or English at applicant?s discretion.
Page 14/23
Issues
Connected problems
QRD Suggestions
considered, e.g.
Page 16/23
Issues
Symbols: Non-Unicode
Connected problems
QRD Suggestions
The use of non-Unicode
Only Unicode symbols must be used in submitted product information annexes.
Page 20/23
Issues
Connected problems
Units: SI base units -
International Standard
litre
base units have been
introduced in the European
Union with Council
Directive 80/181/EEC of
20.12.79 (O.J.
Page 23/23
MADRID, March 5, 2024 /PRNewswire/ -- A new, preclinical study highlights the abilities of a beauty-from-within botanical-blend Zeropollution® to shield skin from the adverse effects of city pollution, especially from free radical damage on a cellular level.
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LOS ANGELES, Feb. 28, 2024 /PRNewswire/ -- Globally celebrated for its premier adult entertainment, Spearmint Rhino today unveils its latest innovation: Rhino Society .