natgillin/translations-raw huggingface dataset:
Ansættelserne vil blive holdt på et forsigtigt niveau, men personaleadministrations aktiviteter vil vokse forholdsvis mere som følge af personaleudskiftninger, intern mobilitet og uddannelse
Recruitment will remain at a conservative level, but personnel and staff administration activities will increase proportionately
Nye spørgsmål, som skal behandles i 2003, og som har indvirkning på arbejdsmængden:
New issues to be faced in 2003 with workload
Undersøgelsen af personaleadministrationen i EMEA vil fortsætte, herunder bestemmelser om deltidsarbejde, revision af præstationsvurderingssystemet og bestemmelserne om intern forflyttelse af ansatte Indførelsen af det computerbaserede personaledata - og personaleforvaltningssystem vil blive afsluttet Indførelse af en videreuddannelsespolitik med henblik på fortløbende kompetenceudvikling Forberedelser til indførelse af EU’ s nye personalevedtægt og tilpasning af interne gennemførelsesbestemmelser Gennemførelse af de nye finansielle bestemmelser for EU og EMEA
Expansion in scope of EMEA activities and enlargement will require further increase in office space, including provision of new delegation offices and meeting rooms
6. 2 Infrastrukturtjenester
personnel data and management system
Den almindelige tekniske udvikling i og diversificering af EMEA’ s aktiviteter gør det nødvendigt at gennemføre en række projekter for at sikre, at agenturets ansatte har passende lokaler, men også for at sikre et egnet arbejdsmiljø og passende faciliteter for ansatte og besøgende.
Provision of improved offsite archiving facilities for the increasing number of files held by the EMEA, together with
Nye spørgsmål, som skal behandles i 2003, og som har indvirkning på arbejdsmængden:
• Implementation of an advanced training policy for continuing competence development
Udarbejdelse og ajourføring af en driftsstabilitetsplan for EMEA Fortløbende uddannelse af det team, som varetager den tekniske bistand i forbindelse med mødelokaler og kontorer Vedligeholdelse af kontorer og offentlige arealer Undersøgelse af EMEA’ s lokalestrategi.
• Preparation for implementation of future new EU Staff Regulations and adaptation of internal implementing rules
Dette omfatter behovet for kontorer, mødelokaler og arealer til teknisk udstyr, især med henblik på den fremtidige udvidelse af EU Vurdering af overholdelsen af arbejdsmiljøbestemmelser og af brand - og evakueringsplaner Forøgelsen af EMEA- aktiviteternes omfang og udvidelsen vil nødvendiggøre en yderligere forøgelse af kontorarealerne, herunder kontorer og mødelokaler til nye delegationer Formidling af forbedrede arkiveringsfaciliteter uden for hjemstedet til det voksende antal sagsakter, som EMEA er i besiddelse af, og forbedret journalforvaltningssystem
• Implementation of new EU and EMEA financial regulations
6. 3 Bogholderi
29
EMEA 2003 Side 36/ 59
Chapter 1 EMEA in the European system 6.3
Antal betalinger modtagne/ foretagne
Accounting
14393 2003 1642
New issues to be faced in 2003 with workload implications:
12955 2002 1752
Number of payments received and made
2001
following reform of the EU financial regulation
1775
20000 • Implementation of improved systems to facilitate reimbursement of meeting expenses and follow-up of fee payment issues with applicants and marketing authorisation 15000 holders 14393 • Upgrading of the SI2 accounting system 12955 10000 5000
10399
10399
5000
•
10000
•
15000
Participation in the development of a review of the EMEA fees
20000
1775
Modtagne betalinger
1752
Foretagne betalinger
1642
Tendenser:
system
Nye spørgsmål, som skal behandles i 2003, og som har indvirkning på arbejdsmængden:
2001
Bilag
2002
EMEA 2003 Side 37/ 59
2003
1.
Chapter 1 Annexes EMEA in the European system 1.
EMEA' s stillingsfortegnelse for 2001 - 2003
EMEA establishment plan 2001– 2003
Sammendrag af EMEA' s budgetter for 2001 – 2003
EMEA budget summaries 2001 – 2003
EMEA’ s vejledningsdokumenter i 2003
EMEA guidance documents in 2003
EMEA' s kontaktpunkter og referencedokumenter
EMEA contact points and reference documents
Profiler af EMEA' s ledende medarbejdere
Profiles of EMEA personalities
Bilag 1 EMEA' s stillingsfortegnelse for 2001 - 2003
31
EMEA 2003 Side 38/ 59
Annex 1 Chapter 1 EMEA in the European system – 2003 establishment plan 2001
Kategori og
Category and Grade
Bev
Occupied as at 31.12.2001
Bevilget i 2002 Besat pr.
Authorised for Occupied as at 2002 31.12.2002
Bevilget i 2003
Authorised for 2003
lønklasse
--
31. 12. 2001
-- --
31. 12. 2002
--
A1 A2 A3 A4 A5 A6 A7 A8
A2
-- 1 4 26 24 24 24 --
1
-- 1 5 29 28 29 30 --
1
-- 1 5 28 26 24 30 --
29 24
-- 1 5 32 32 34 32 --
-- -- --
I ALT A B1 B2 B3 B4 B5 I ALT B C1 C2 C3 C4 C5 I ALT C D1 D2 D3 D4 I ALT D
TOTAL A B1
103 4 8 9 5 5 31 14 13 42 -- -- 69 1 4 -- -- 5
103 4
122 4 9 11 9 8 41 15 19 44 4 -- 82 1 5 -- -- 6
122 4
114 2 8 10 8 6 34 15 19 43 4 -- 81 1 5 -- -- 6
114 2
136 6 10 12 12 9 49 19 23 47 6 -- 95 2 5 -- -- 7
10
STILLINGER I ALT
TOTAL B C1
208
31 14
251
41 15
235
34 15
287
49 19
EMEA’ s arbejdsprogram for 2003 EMEA/ MB/ 057/ 02/ da/ Endelig udg.
C5
EMEA 2003 Side 39/ 59
-- -- --
(Alle beløb er angivet i euro)
TOTAL C D1
2001( 1)
81 1
2002( 2)
95 2
2003( 3)
D2
(31. 12. 2001)
4
(31. 12. 2002)
5
(19. 12. 2002)
5
45 14
5
39 17
D3
000 000 135 000
-- -- --
63, 58% 27, 95%
--
48 15
D4
142 000 500 000
-- -- --
--
TOTAL D
--
5
--
6 6
000 000
TOTAL POSTS
8, 97%
251
til sjældne sygdomme Bidrag fra EØS Bidrag fra EU- programmer
235
600 000 287 640
287
2
3 2 EMEA Work Programme 2003
750 000 366 000
(Amounts expressed in euro)
4, 49% 0, 60%
2001
3
(1)
300 000 558 000
2002
4, 23% 0, 71%
(2)
(PERF)
2003
2
(3)
314 360
(31.12.2001)
3, 51%
(31.12.2002)
231 000
(19.12.2002)
0, 38%
Revenue
1
Fees General EU contribution Special EU contribution for IT telematics strategy Special EU contribution for orphan medicinal
430 000
45 771 000 14 700 000 --
1, 83%
69.49% 22.32% --
Andre
39 000 000 17 135 000 --
193 000
63.58% 27.95% --
3, 33%
61.66% 19.85% 8.97%
1
600 000 287 640 2 314 360 2 193 000
840 000
0.91% 0.44% 3.51% 3.33%
3, 00%
2 750 000 366 000 231 000 1 840 000
2
4.49% 0.60% 0.38% 3.00%
151 000
3 300 000 558 000 1 430 000 2 151 000
2, 75%
4.23% 0.71% 1.83% 2.75%
866 000
65 866 000
304 000 100, 00%
61 304 000 100.00%
081 000
78 081 000
Vederlag Vikarer og andre hjælpeansatte Andre personalerelaterede udgifter
Salaries Interim and o ther support persons Other staff-related expenditure
615 000 414 000 683 640
20 615 000 1 414 000 1 683 640
31, 30% 2, 15% 2, 56%
31.30% 2.15% 2.56%
24 1 1
24 850 000 1 760 000 1 502 000
850 000 40, 54% 760 000 2, 87% 502 000 2, 45%
40.54% 2.87% 2.45%
130 000 845 000 213 000
29 130 000 1 845 000 2 213 000
37, 31% 2, 36% 2, 83%
37.31% 2.36% 2.83%
Afsnit 1 i alt Bygninger og udstyr
Total title 1
23
23 712 640
36, 00%
36.00%
28
28 112 000
112 000 45, 86%
45.86%
33
33 188 000
188 000
42.50%
42, 50%
Building/equipment
Husleje/ afgifter Udgifter til databehandling Andre kapitaludgifter Porto og telekommunikation
Rent/charges Expenditure on data processing Other capital expenditure Postage and communications Other administrative expenditure
149 000 293 000 658 000 617 000
5 149 000 4 293 000 1 658 000 617 000 1 829 000
7, 82% 6, 52% 2, 52% 0, 94%
7.82% 6.52% 2.52% 0.94% 2.78%
572 000 9, 09% 570 000 4, 19% 381 000 0, 62% 264 000 0, 43%
5 572 000 2 570 000 381 000 264 000 2 107 000
6 6
9.09% 4.19% 0.62% 0.43% 3.44%
275 000 250 000 627 000 418 000
6 275 000 6 250 000 627 000 418 000 2 083 000
8, 04% 8, 00% 0, 80% 0, 54%
8.04% 8.00% 0.80% 0.54% 2.67%
829 000 546 000
13 546 000
2, 78% 20, 57%
20.57%
2 10
10 894 000
107 000 3, 44% 894 000 17, 77%
17.77%
2 15
15 653 000
083 000 653 000
20.05%
2, 67% 20, 05%
Operational expenditure
4 21
4 110 000
110 000 308 000 428 000 225 000 190 000
6.24%
3 17
3 535 000
535 000 5, 77% 855 500 29, 13% 477 000 0, 78% 98 500 0, 16% 119 000 0, 19%
5.77%
4 21
4 920 000
EU- programmer
6.30%
2
Evaluations Translation Studies and consultants Publications EU programmes
346 360
21 308 000 428 000 225 000 190 000 2 346 360
3, 56%
32.35% 0.65% 0.34% 0.29% 3.56%
213 000 0, 34%
17 855 500 477 000 98 500 119 000 213 000
1
29.13% 0.78% 0.16% 0.19% 0.34%
430 000
21 941 000 451 000 350 000 148 000 1 430 000
1, 83%
28.10% 0.58% 0.45% 0.19% 1.83%
43, 43%
43.43%
22
22 298 000
298 000 36, 37%
36.37%
240 000
29 240 000
37, 45%
37.45%
65 866 000
65 866 000
61 304 000 100, 00%
100.00% 61 304 000 100.00%
78 081 000
78 081 000
(1) Endelige bevillinger opført på budgettet for 2001.
Notes (1) Final appropriations for the 2001 budget.
(2) Endelige bevillinger opført på budgettet for 2002.
(2) Final appropriations for the 2002 budget.
(3) Budgettet for 2003 som vedtaget af bestyrelsen den 19. 12. 2002.
(3) Budget for 2003 adopted by the Management Board on 19.12.2002.
Bilag 3 EMEA' s vejledningsdokumenter for 2003
Annex 3 EMEA guidelines for 2003 The following documents are intended to be finalised or released for consultation in 2003:
EMEA 2003 Side 40/ 59
Points to consider on clinical investigation of medicinal products for treatment of rheumatoid arthritis
Det er hensigten, at følgende dokumenter afsluttes eller sendes til høring i 2003:
Points to consider on the evaluation of medicinal products for
Titel på dokumentet Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Expression in Higher Plants Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products Points to Consider on the Development of Live Attenuated Influenza Vaccines
Appendix to the Note for Guidance on the Clinical investigation Document title of medicinal products in the treatment of schizophrenia Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products
CPMP- arbejdsgruppe vedrørende blodpræparater
containing Active Substances Produced by Stable Transgene Expression in Higher Plants
Titel på dokumentet Note for Guidance on the Clinical investigation of plasma derived fibrin sealants Note for guidance on the Clinical investigation of von Willebrand factor Warning on transmissible agents for patient leaflets and SPCs Core SPC for Plasma derived fibrin sealants
Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products Points to Consider on the Development of Live Attenuated
CPMP- arbejdsgruppe vedrørende virkninger
Influenza Vaccines
Titel på dokumentet Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI) Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection.
Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine.
Note for Guidance on Clinical Investigation of Medical Products CPMP Blood Product Working Party in the Treatment of Panic Disorder
Note for Guidance on evaluation of anticancer medicinal products in man (CPMP/ EWP/ 205/ 95 rev.
Document title Note for Guidance on the Clinical investigation of plasma derived
Points to consider on the evaluation of new anti- fungal agents for invasive fungal infections.
Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Obsessive-compulsive Disorder
Points to consider on clinical investigation of medicinal products for treatment of rheumatoid arthritis.
fibrin sealants Note for guidance on the Clinical investigation of von Willebrand factor Warning on transmissible agents for patient leaflets and SPCs Core SPC for Plasma derived fibrin sealants
Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome.
Addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia Note for Guidance on Clinical investigation of steroid contraceptives in women
Appendix to the Note for Guidance on the Clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/ EWP/ 559/ 95) – methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia.
Revision of Note for Guidance on evaluation of new anti- bacterial medicinal products (CPMP/EWP/558/95) and Note for
Points to consider on the requirements for clinical documentation for metered dose inhalers (MDI) Addendum on neuropathic pain to the Note for Guidance on clinical investigation of medicinal products for nociceptive Pain treatment Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Panic Disorder.
Document title Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI)
Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Obsessive- compulsive Disorder Addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia Note for Guidance on Clinical investigation of steroid contraceptives in women Revision of Note for Guidance on evaluation of new anti- bacterial medicinal products (CPMP/ EWP/ 558/ 95) and Note for Guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial medicinal products
Choice of Non-
Titel på dokumentet
Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection
EMEA 2003 Side 41/ 59
inferiority margin Points to consider on Biostatistical/methodological issues arising
Points to consider on Biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Adjustment for baseline covariates
Choice of Non- inferiority margin Points to consider on Biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
2) – Addendum on paediatric oncology
Adjustment for baseline covariates Points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials Points to consider on clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment Note for guidance on clinical investigation of medicinal products for the treatment of psoriasis Points to consider on allergic rhino- conjuctivitis Addendum to the Note For Guidance on Modified Release Oral and Transdermal Dosage Forms:
Points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials Points to consider on clinical pharmacokinetic investigation of
Section II (PharmacoKinetic and Clinical Evaluation) on the clinical requirements of modified release products submitted as a line - extension of an existing marketing authorisation Points to consider on Xenogenic Cell Therapy Note for Guidance on Comparability of Medicinal Products containing biotechnology - derived proteins as active substance Note for Guidance on the use of medicinal products during pregnancy Note for Guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
the pharmacokinetics of peptides and proteins Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function
CPMP- arbejdsgruppe vedrørende sikkerhed
Chapter 1 EMEA in the European system
Annex on Non- Clinical and Clinical Considerations Note for Guidance on the Non- Clinical Documentation of Medicinal Products with Well- Established Use Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre- clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals
Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population Note for guidance on the evaluation of the pharmacokinetics of
CPMP- arbejdsgruppe vedrørende lægemiddelovervågning
CPMP Pharmacovigilance Working Party Document title
Titel på dokumentet Note for Guidance on Criteria for Recall and Repackaging Following Urgent Safety Restriction and Variation Procedures CPMP Points- to- Consider Document on Xenogeneic Cell Therapy (CPMP/ 1199/ 02) ICH- V1:
Note for Guidance on Criteria for Recall and Repackaging Following Urgent Safety Restriction and Variation Procedures
Clinical Safety Data Management:
Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs – Addendum to ICH- E2C (CPMP/ ICH/ 4679/ 02) ICH- V2:
Periodic Safety Update Reports for Marketed Drugs – Addendum to ICH-E2C (CPMP/ICH/4679/02)
Post- Approval Safety Management:
Post-Approval Safety Management:
Definitions and Standards for Expedited Reporting and Good Case Management Practices ICH- V3:
Definitions and Standards for Expedited Reporting and Good Case Management Practices ICH-V3:
Prospective Planning of Pharmacovigilance Notice to Applicants – Guideline on the Summary of Product Characteristics (EC December 1999 – Revised Version)
Notice to Applicants – Guideline on the Summary of Product Characteristics (EC December 1999 – Revised Version)
EMEA’ s arbejdsprogram for 2003 EMEA/ MB/ 057/ 02/ da/ Endelig udg.
Note for Guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
EMEA' s arbejdsgruppe vedrørende urtemedicin
CPMP Herbal Medicinal Products Working Party Document title
EMEA 2003 Side 42/ 59
Note for guidance on non-clinical testing of herbal drug
Titel på dokumentet
CPMP Safety Working Party Document title
Note for guidance on non- clinical testing of herbal drug preparations with long- term marketing experience - guidance to facilitate mutual recognition and use of bibliographic data Concept paper for a Note for Guidance on the investigation of biopharmaceutical characterisation and bioavailability/ bioequivalence of herbal drugs/ preparations Position paper on the risk associated with the use of herbal products containing estragole Position paper on the risk associated with the use of herbal products containing methyleugenol Position paper on the risk associated with the use of herbal products containing á - and β- asarone Position paper on the use of Sassafras albidum as active substance or ingredient in herbal medicinal products Concept paper on the levels of scientific evidence required for the authorisation of well- established use and traditional herbal medicinal products Core- data on Urticae radix Core- data on Lini semen Core- data on Rosmarini folium cum flore Core- data on Primulae Radix
preparations with long-term marketing experience - guidance to facilitate mutual recognition and use of bibliographic data Concept paper for a Note for Guidance on the investigation of
CVMP- arbejdsgruppe vedrørende virkninger
Annex on Non-Clinical and Clinical Considerations
Titel på dokumentet Antimicrobials for general use in target animal species Summary of product characteristics for antimicrobial products Efficacy requirements for ectoparasiticides for cattle Fluid therapy
biopharmaceutical characterisation and bioavailability/ bioequivalence of herbal drugs/preparations Position paper on the risk associated with the use of herbal products containing estragole Position paper on the risk associated with the use of herbal products containing methyleugenol Position paper on the risk associated with the use of herbal
CVMP- arbejdsgruppe vedrørende immunologiske veterinærlægemidler
Note for Guidance on the Non-Clinical Documentation of Medicinal Products with Well-Established Use
Testing for the detection of mycoplasma contamination VICH:
products containing α- and β-asarone Position paper on the use of Sassafras albidum as active
Target animal safety for veterinary biological products VICH:
Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre-clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals
Tests on the presence of extraneous viruses in veterinary viral vaccines
substance or ingredient in herbal medicinal products Concept paper on the levels of scientific evidence required for the authorisation of well-established use and traditional herbal medicinal products Core-data on Urticae radix
CVMP- arbejdsgruppe vedrørende lægemiddelovervågning
Core-data on Lini semen
Management of adverse event reports VICH:
Core-data on Rosmarini folium cum flore
Controlled list of terms VICH:
Core-data on Primulae Radix
CVMP- arbejdsgruppe vedrørende sikkerhed
Chapter 1 EMEA in the European system CVMP Efficacy Working Party
EMEA 2003 Side 43/ 59
CVMP Safety Working Party
VICH:
VICH:
Pre- approval information for registration of new medicinal products for food producing animals with respect antimicrobial resistance Injection site residues User safety
Pre-approval information for registration of new medicinal products for food producing animals with respect to antimicrobial resistance Injection site residues User safety
to
CVMP Immunologicals Working Party Document title Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Estimation of predicted environmental concentrations, including harmonisation of default values and development of a harmonised computer model Toxicity of substances to dung fauna Degradation of substances in manure
harmonisation of default values and development of a harmonised computer model Toxicity of substances to dung fauna Degradation of substances in manure
Fælles CPMP/ CVMP- arbejdsgruppe vedrørende kvalitet
Testing for the detection of mycoplasma contamination VICH:
Titel på dokumentet Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Joint CPMP/CVMP Quality Working Party Document title Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
European Drug Master File Declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active substances:
European Drug Master File Declaration of storage conditions for pharmaceutical veterinary medicinal products in the product particulars and active
Annex:
Annex:
Stability testing of new active substances and medicinal products Annex:
Stability testing of new active substances
EMEA’ s arbejdsprogram for 2003 EMEA/ MB/ 057/ 02/ da/ Endelig udg.
Tests on the presence of extraneous viruses in veterinary
EMEA 2003 Side 44/ 59
and medicinal products Annex:
Lægemiddelovervågning og indberetning af produktfejl
Stability testing of existing active
Den fortløbende overvågning af lægemidlers sikkerhed efter udstedelse af tilladelse (‘ lægemiddelovervågning ’) er en vigtig del af de nationale kompetente myndigheders og EMEA’ s arbejde.
viral vaccines
Spørgsmål om lægemiddelovervågning af humanmedicinske lægemidler
substances and related finished products
(direkte nummer) (44- 20) 75 23 71 08 E- mail: panos. tsintis@ emea. eu. int
Summary of requirements for active substances
Spørgsmål om lægemiddelovervågning af veterinærlægemidler
Management of adverse event reports
Barbara FREISCHEM Tlf.:
drinking water