Glossary entry (derived from question below)
Spanish term or phrase:
identidad de origen
English translation:
identity of the origin of the trademarked product (see the SmPC and/or PIL)
Spanish term
identidad de origen
https://s31.postimg.org/qwfhiqmjf/identidad_de_origen.png
If need be, I'll be happy to provide further context. Thanks for your time and attention!
| 4 | identity of the origin of the trademarked product (see the SmPC and/or PIL) |
Erzsébet Czopyk
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Aug 30, 2016 20:19: Erzsébet Czopyk Created KOG entry
Non-PRO (1): Yvonne Gallagher
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Proposed translations
Hungary
sworn translator, linguist, DPO
Native in: Hungarian (Variant: Hungary) 
Works in: Russian to Hungarian, Hungarian to Russian, Latvian to Russian, and 10 more.
identity of the origin of the trademarked product (see the SmPC and/or PIL)
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance ****, a lyophilised mixture containing these different fractions:
*** mg specified as **** content
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and breast-feeding
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT
Part B Checklist for MIV-1 Applications for ... - Health Sciences Authority
www.hsa.gov.sg/.../Part B Checklist for MIV-1 Ap...
Result of all identity testing, including cytogenetic characteristics that could be used to .... Approved PI/SmPC/PIL from an approved reference regulatory agency or the country of origin containing the proposed changes (where applicable).
pdf - Durham e-Theses - Durham University
etheses.dur.ac.uk/2135/1/2135_143.PDF?UkUDh:CyT
SPC. Supplementary Protection Certificate. SSNIP. Small but Significant .... 'parallel import licence' (PIL) will be granted by a competent national authority .... national authorities and the European Medicines Agency (EMEA)^^ are frequently ...... identity of the origin of the trademarked product to the consumer or ultimate user,.
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Note added at 1 hr (2016-07-28 22:56:51 GMT)
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Validation of Analytical Procedures - European Medicines Agency
www.ema.europa.eu/docs/en_GB/document.../WC500002662.pdf
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended ... Identification tests are intended to ensure the identity of an analyte in a sample. This is ... This definition has the following implications:.
[PDF]Guideline on Cell based Medicinal Products - European Medicines ...
www.ema.europa.eu/docs/en_GB/document.../WC500003898.pdf
- materials, on the design and validation of the manufacturing ... Also, procurement and testing of cells from human origin must ... Identity should be verified by relevant genotypic and phenotypic markers and the proportion.
European Medicines Agency - GMP/GDP compliance - Questions and ...
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q...
European Union (EU) GMP guide part I: Basic requirements for medicinal ..... for identity testing of every container where there is a validated supply chain.
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Note added at 32 days (2016-08-30 20:19:43 GMT) Post-grading
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Thank you very much.
Discussion
KudoZ term not found.