REG Regulatory Application

To describe what regulatory requirements are associated with the product.

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Position

Element

Name

Type

Requirement

Min

Max

Repeat

Regulatory Type

Identifier (ID)

Mandatory

2

2

1

Type of legislation.

REG01 identifies the regulatory type, REG02 and REG03 identify where the regulation pertains, and REG04 confirms the applicability.

Country Code

Identifier (ID)

Conditional

2

3

1

Code identifying the country

R0203: At least one of REG-02 or REG-03 is required

REG02 is recommended, if there is a possibility of confusion when declaring the State or Province code.

REG-03

Composite State or Province Code

Composite (composite)

Conditional

1

State or Province Code

Identifier (ID)

Mandatory

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

State or Province Code

Identifier (ID)

Optional

2

2

-

Code specifying the Standard State/Province as defined by appropriate government agency

Yes/No Condition or Response Code

Identifier (ID)

Optional

1

1

1

Code indicating a Yes or No condition or response

REG04 declares the relationship of REG01 with REG02 and REG03.