Regulatory Affairs

1. REGULATORY
OVERVIEW-
DENMARK
PRESENTED BY:
GERALDO GARCIA
AAPS - PHARMACEUTICAL QA/QC
PRA 3008
GLOBAL REGULATORY AFFAIRS
APRIL 26, 2016
SUBMITTED TO:
PROF. PEIVAND PIROUZI, PHD, MBA, CCPE
AAPS REGULATORY AFFAIRS
PROGRAM DIRECTOR

2. TOPICS COVERED
•REGULATORY OVERVIEW
•PRICING AND STATE FUNDING
•MANUFACTURING
•REGULATORY POWERS
•CLINICAL TRIALS
•MARKETING
•ADVERTISING
•PACKAGING AND LABELLING
•PATENTS
•TRADEMARKS
•PRODUCT LIABILITY
•REFORMS

3. REGULATORY OVERVIEW
•MEDICINAL PRODUCTS
ARE PRIMARILY
REGULATED BY ACT NO.
1180 OF 12 DECEMBER
2005 OR MEDICINES ACT.

4. THE MEDICINES ACT REGULATES ISSUES SUCH AS:
CLINICAL TRIALS
PRICING
MARKETING AUTHORISATIONS
ADVERTISING
LABELLING
SIDE EFFECTS
MANUFACTURING AUTHORISATIONS
QUALITY OF MEDICINAL PRODUCTS

5. DKMA
• AUTHORISATION BODY
• INSPECTS
• TAKE SAMPLES
• REVOKE LICENSES
• PROHIBIT AND WITHDRAW
MANUFACTURED PRODUCTS
• RESPONSIBLE FOR ALL ASPECTS OF
MEDICINAL PRODUCTS
DKMA
Content/
composition
Quality
Storage
Manufacture
Danish Medicines Agency (Lægemiddelstyrelsen)

6. HEALTH CARE SYSTEM
Health Care
System
Sectors
Primary
Sector
Doctors Nurses
Secondary
Sector
Hospitals

7. DISTRICT
NURSES AND
SCHOOL
HEALTHCARE
Health Care
System
Administration
State Regions Municipalities
PUBLIC
HOSPITALS
LAWS

8. PRICING AND REIMBURSEMENT
REGULATION OF MEDICINAL
PRODUCTS
• AN OPEN-MARKET PRICING
STRUCTURE APPLIES
• CHARACTERIZED BY THE ABSENCE
OF TARIFFS, TAXES, LICENSING
REQUIREMENTS, SUBSIDIES,
UNIONIZATION AND ANY OTHER
REGULATIONS OR PRACTICES
REIMBURSEMENT OF
MEDICINAL PRODUCTS
• THE REIMBURSEMENT IS
AUTOMATICALLY DEDUCTED FROM
THE PRICE AT THE PHARMACY

9. APPLICATION PROCESS FOR DRUG MANUFACTURING
Submission
Processing
and Fee
Validity
- 90 DAYS VALID FOR
THREE YEARSDKMA - DKK15,039 (US$2,960)
- DKK15,366 ( US$3,020)
- DKK6,489 (US$1,280)

10. CLINICAL TRIALS
• REGULATED BY SECTIONS 88 TO 92 OF THE
MEDICINES ACT
• APPROVED BY DKMA AND ETHICAL SCIENCE
COMMITTEE
• RISK
• SCIENTIFIC STANDARD OF THE PROJECT
• PARTICIPANTS HAVE TO BE FULLY BRIEFED
• WRITTEN DOCUMENTATION OF FINANCIAL
SUPPORT
• GLP
• SUFFICIENT GROUNDS FOR THE TRIALDKK7,010 (about US$1,380)

11. MARKETING
CONDITIONS
• BE OF SATISFACTORY QUALITY
• BE SAFE TO USE
• HAVE THE DESIRED EFFECT
FEES
• DKK75,124 (ABOUT US$14,770)
• ANNUAL FEE IS DKK8,414 (ABOUT US$1,650)
• RENEWAL FEE IS DKK16,385 (ABOUT US$3,220)
VALIDITY
• VALID FOR 5 YEARS
• RENEWALS MUST BE SUBMITTED BEFORE
3 MONTHS OF EXPIRATION
• AUTHORISATIONS NOT USED WITHIN 3
YEARS WILL LAPSE

12. PARALLEL IMPORTS OF DRUGS
CONDITIONS
• THE DIRECTLY DISTRIBUTED PRODUCT MUST HAVE A MARKETING AUTHORISATION IN
DENMARK
• THE PARALLEL IMPORTED PRODUCT MUST COME FROM ANOTHER EU STATE
• THE PRODUCT MUST HAVE A MARKETING AUTHORISATION IN ANOTHER EU MEMBER
STATE
• THERE MUST BE NO DIFFERENCES OF THERAPEUTIC SIGNIFICANCE BETWEEN THE
PARALLEL IMPORT AND THE ORIGINAL PRODUCT

13. REPACKAGING
• THERE IS LEGISLATION ON THE USE OF A SPECIFIC PACK SIZE.
• THERE ARE NATIONAL HEALTH RULES UNDER WHICH ONLY CERTAIN PACK
SIZES ARE REIMBURSABLE.
• THERE IS A FIXED PRESCRIPTION PRACTICE.
PACKAGING AND LABELLING
• FOREIGN LANGUAGES ARE ACCEPTABLE
• A LABEL WITH DANISH TEXT CAN BE PLACED OVER FOREIGN TEXT
• IF IMPORTED PRODUCTS DIFFER IN COLOR, TASTE, AND APPEARANCE, A
WARNING LABEL MUST BE DISPLAYED

14. MARKETING OF MEDICINAL PRODUCTS ON INTERNET,
E-MAIL, AND MAIL ORDER
CONDITIONS
• INTENDED FOR PERSONAL USE AND FOR PREVENTION OR TREATMENT OF AN
ILLNESS
• SOLD BY A PHARMACY
• DISPATCHED FROM A COUNTRY WHICH IS AN EU MEMBER
• MEDICINAL PRODUCT DOES NOT CONTAIN EUPHORIANT SUBSTANCES

15. ADVERTISING
PROHIBITION
• REGULATED BY SECTIONS 63 TO 71C
OF THE MEDICINES ACT
• ILLEGALLY SOLD DRUGS
• MEDICINAL PRODUCTS FOR NON-CLINICAL TRIALS AND CLINICAL TRIALS
• MAGISTRAL MEDICINAL PRODUCTS (THAT IS, MEDICINAL PRODUCTS THAT
ARE PREPARED FOR AN INDIVIDUAL PERSON ON INSTRUCTIONS FROM A
DOCTOR).
• DRUGS NOT COVERED BY MEDICINAL AUTHORISATION

16. ADVERTISING FOR MEDICINAL PRODUCTS (BOTH
PRESCRIPTION-ONLY AND OTC) MUST:
Adequate
Objective
product
characteristics
Not mislead
Not
exaggerate
• NAME
• APPLICATION
• ADVERSE EFFECTS
• RISKS
• PRICE

17. PACKAGING AND LABELLING
THE INFORMATION ABOUT THE MEDICINAL PRODUCT
SHOULD INCLUDE:
• NAME
• STRENGTH
• PHARMACEUTICAL FORM
• PACKAGE SIZE
• USE AND ROUTE OF ADMINISTRATION
• TECHNICAL INFORMATION
• INDICATION
• STORAGE CONDITIONS
• BATCH NUMBER AND EXPIRY DATE
• NAME AND ADDRESS OF
AUTHORISATION HOLDER
• MARKETING AUTHORISATION NUMBER
• SPECIAL PRECAUTIONS IF ANY FOR
PRODUCT DISPOSAL

18. TRADITIONAL HERBAL MEDICINES
HERBAL MEDICINAL PRODUCTS CONTAIN NATURALLY OCCURRING
SUBSTANCES
• CAN BE USED WITHOUT SUPERVISION OF MEDICAL PRACTITIONER
• ADMINISTERED ACCORDING TO SPECIFIED STRENGTH
• ORAL, EXTERNAL, AND/OR INHALATION PREPARATION
• USED FOR 30 YEARS
• NOT HARMFUL TO SPECIFIED USE

19. Patents
New
Inventive
Step
Industrial
Application
• APPLICATION FEE IS DKK3,000 (ABOUT
US$590), WHICH COVERS TEN PATENT
CLAIMS
• EACH ADDITIONAL PATENT CLAIM IS DKK300
(ABOUT US$60)
• FOR THE FIRST THREE YEARS, THE ANNUAL
FEE IS DKK500 (ABOUT US$100)
FEE
DANISH PATENT AND TRADEMARK OFFICE

20. TRADE MARKS
• THE NAME OF THE BRAND IS DISTINCT
• THE BRAND IS NOT DESCRIPTIVE
• TRADE MARKS MUST BE USED FIVE YEARS AFTER THE END OF THE REGISTRATION
PROCEDURE
• A TRADE MARK IS PROTECTED FOR TEN YEARS
FEE
• THE APPLICATION FEE IS DKK2,350 (ABOUT US$460)
• ADDITIONAL FEE OF DKK600 (ABOUT US$120) IS REQUIRED FOR EACH
REGISTERED CATEGORY IF THERE ARE MORE THAN THREE.

21. PRODUCT LIABILITY
• THE MEDICINAL PRODUCT WAS NOT
DEFECTIVE
• THE MEDICINAL PRODUCT DID NOT
CAUSE THE DAMAGE
• THE DAMAGED PERSON CAUSED
THE DAMAGE BY NEGLIGENCE
MANUFACTURER OR THE
SUPPLIER IS LIABLE IF :
• THE MEDICINAL PRODUCT IN
QUESTION IS DEFECTIVE.
• THE USER OF THE PRODUCT IS
INJURED
• THE INJURED PERSON IS ABLE TO
PROVE THE DAMAGE
DEFENCES ARE AVAILABLE TO
PRODUCT LIABILITY CLAIMS: